Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Genre Guideline ✖

1. Health document submission requirements for tobacco products: (revised)

Publication:: Silver Spring, MD : Center for Tobacco Products, October 2017
Subject(s):: Documentation -- standards
Tobacco Products -- standards
Drug Approval
Health
Terminology as Topic
Tobacco Products -- adverse effects
Tobacco Products -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

2. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Registries -- standards
Tobacco Products -- standards
Manufacturing and Industrial Facilities -- standards
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

3. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Regulatory classification of pharmaceutical co-crystals

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Chemistry, Pharmaceutical -- classification
Chemistry, Pharmaceutical -- standards
Crystallization -- classification
Investigational New Drug Application
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Muscular Dystrophies -- drug therapy
Muscular Dystrophy, Duchenne -- drug therapy
Drug Labeling -- standards
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. How to prepare a pre-request for designation (pre-RFD)

Publication:: [Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018
Subject(s):: Equipment and Supplies -- classification
Drugs, Investigational -- classification
Investigational New Drug Application
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Migraine: developing drugs for acute treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation -- standards
Migraine Disorders -- drug therapy
Acute Disease
Adult
Child
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Clinical Trials as Topic -- ethics
Clinical Trials as Topic -- methods
Ethics Committees, Research
Informed Consent
Randomized Controlled Trials as Topic -- ethics
Randomized Controlled Trials as Topic -- methods
Research Design
Research Subjects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

11. E18 genomic sampling and management of genomic data

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Data Collection -- standards
Genomics -- standards
Specimen Handling -- standards
Confidentiality
Genetic Testing
Genotyping Techniques
Information Management -- standards
Informed Consent
International Cooperation
Privacy
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Patient Outcome Assessment
Patient Reported Outcome Measures
Pulmonary Disease, Chronic Obstructive -- therapy
Surveys and Questionnaires
Clinical Trials as Topic
Outcome Assessment (Health Care)
Self-Assessment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Drug Compounding -- standards
Liposomes -- chemistry
Liposomes -- pharmacokinetics
Biological Availability
Chemistry, Pharmaceutical
Liposomes -- administration & dosage
Liposomes -- therapeutic use
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018
Subject(s):: Genetic Testing
Germ-Line Mutation
Diagnostic Test Approval
Reagent Kits, Diagnostic -- standards
Sequence Analysis, DNA
Genomics
Reproducibility of Results
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018
Subject(s):: Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
Access to Information
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Listing of ingredients in tobacco products: (revised)

Publication:: Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, April 2018
Subject(s):: Tobacco Products -- standards
Manufactured Materials -- standards
Tobacco
Tobacco Industry -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

18. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Quality Control
Drug Contamination
Drug Labeling -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Special protocol assessment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Protocols -- standards
Clinical Trials as Topic -- standards
Drug Approval
Drug Evaluation, Preclinical -- standards
Research Design
Carcinogenicity Tests -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Clinical trial imaging endpoint process standards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- standards
Diagnostic Imaging -- standards
Endpoint Determination -- standards
Research Design -- standards
Observer Variation
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

21. Assessing user fees under the Prescription Drug User Fee Amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

22. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Blood Specimen Collection -- methods
Drug Evaluation, Preclinical -- methods
Pharmaceutical Preparations -- administration & dosage
Sample Size
Toxicity Tests -- methods
Toxicokinetics
Pharmacokinetics
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Drug Compounding -- standards
Drug Industry -- standards
Contract Services
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

24. Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Endpoint Determination
Hypogonadism -- drug therapy
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

25. Acne vulgaris: establishing effectiveness of drugs intended for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

26. Bioanalytical method validation

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27. Enforcement policy--OTC sunscreen drug products marketed without an approved application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Health Policy
Marketing
Sunscreening Agents
Consumer Product Safety
Product Labeling
Sun Protection Factor
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

28. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

29. Complicated intra-abdominal infections: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
Drug Labeling -- standards
Endpoint Determination -- standards
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

30. Complicated urinary tract infections: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Anti-Infective Agents, Urinary -- therapeutic use
Clinical Trials as Topic -- standards
Drug Evaluation
Microbiological Techniques -- standards
Urinary Tract Infections -- drug therapy
Endpoint Determination -- standards
Research Design -- standards
Urinary Tract Infections -- complications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

31. Medical product communications that are consistent with the FDA-required labeling: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Communication
Drug Labeling -- standards
Product Labeling -- standards
Equipment and Supplies -- standards
Pharmaceutical Preparations -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

32. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

33. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018
Subject(s):: Electronic Health Records
Health Information Interoperability
Logical Observation Identifiers Names and Codes
Reagent Kits, Diagnostic
Device Approval
In Vitro Techniques -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

34. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

35. Assessing user fees under the biosimilar user fee amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
Drug Evaluation -- economics
Parenteral Nutrition Solutions -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

36. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

37. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, July 2018
Subject(s):: Blood Component Transfusion
Blood Safety -- standards
Blood Transfusion
Zika Virus Infection -- blood
Zika Virus Infection -- transmission
Blood Donors
Zika Virus Infection -- epidemiology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

38. E17 general principles for planning and design of multiregional clinical trials

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Research Design
Demography
Endpoint Determination
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

39. Use of electronic health record data in clinical investigations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Clinical Trials as Topic
Electronic Health Records -- utilization
Health Information Interoperability
Forms and Records Control
Informed Consent
Reproducibility of Results
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

40. Labeling for biosimilar products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Biosimilar Pharmaceuticals
Drug Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

41. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):: Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

42. Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Product Labeling -- standards
Tobacco Products -- standards
Tobacco Industry -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

43. Elemental impurities in drug products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Chemistry, Pharmaceutical
Drug Contamination
Quality Control
International Cooperation
Investigational New Drug Application
Reproducibility of Results
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

44. Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Chemistry, Pharmaceutical
Drug Liberation
Solubility
Dosage Forms
Therapeutic Index, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

45. Quality attribute considerations for chewable tablets

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Chemistry, Pharmaceutical
Drug Liberation
Mastication
Quality Control
Solubility
Tablets -- pharmacokinetics
Drug Approval
Drug Labeling
Hardness
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

46. Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Drug Evaluation, Preclinical
Radiopharmaceuticals -- administration & dosage
Radiopharmaceuticals -- pharmacokinetics
Diagnostic Imaging
Diagnostic Uses of Chemicals
Radiopharmaceuticals -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

47. Physiologically based pharmacokinetic analyses--format and content

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Drug Evaluation, Preclinical
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Research Design
Software
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

48. Allergic rhinitis: developing drug products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

49. Nonallergic rhinitis: developing drug products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Rhinitis -- drug therapy
Adult
Chemistry, Pharmaceutical
Child
Patient Selection
Pediatrics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

50. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):: Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

51. Code of ethics of the Massachusetts Medical Society: adopted by the councillors, Feb. 4, 1880

Author(s):: Massachusetts Medical Society, author.
Publication:: [Massachusetts?] : [publisher not identified], [1880?]
Subject(s):: Societies, Medical
Codes of Ethics
Massachusetts
Massachusetts Medical Society.

52. Medical reference data for staff officers

Publication:: Orlando, Florida : Army Air Forces School of Applied Tactics, Army Air Forces Tactical Center, [1944?]
Subject(s):: Aerospace Medicine -- organization & administration
Military Medicine -- organization & administration
Aerospace Medicine -- standards
Military Medicine -- standards
Military Personnel
United States

53. Industrial hygiene problems in Bolivia, Peru, and Chile

Author(s):: Bloomfield, J. J. (John Jacob), 1897-1977
Publication:: Washington, D.C. : Federal Security Agency, Public Health Service, 1948
Subject(s):: Occupational Health
Occupational Diseases
National Health Programs
Public Health
Bolivia
Chile
Peru

54. Communicable diseases, quarantine rules and regulations

Publication:: [Los Angeles] : Office of the Superintendent, Los Angeles City Schools, 1948
Subject(s):: Communicable Disease Control
Schools
California

55. Operations in snow and extreme cold

Author(s):: United States. War Department. General Staff, author.
Publication:: Washington : Government Printing Office : For sale by the Superintendent of Documents, 1941
Subject(s):: Cold Temperature
Snow
Warfare
Military Science

56. A manual of public health nursing

Author(s):: Texas. Public Health Nursing Division, author, issuing body.
Publication:: Austin, Texas : Public Health Nursing Division, Texas State Department of Health, 1949
Subject(s):: Public Health Nursing
Nurses, Public Health
Texas

57. Manual for public health nurses

Author(s):: New Mexico. Division of Public Health Nursing, author, issuing body.
Publication:: Santa Fe : State of New Mexico, Department of Public Health, 1949
Subject(s):: Public Health Nursing
Nurses, Public Health
New Mexico

58. Regulations and procedure

Author(s):: United States. Veterans Administration, author, issuing body.
Publication:: Washington, D.C. : Veterans Administration, [1946?]
Subject(s):: Delivery of Health Care -- organization & administration
Hospitals, Veterans -- standards
Veterans Health
United States

59. Operations in snow and extreme cold

Author(s):: United States. War Department, author.
Publication:: Washington : Government Printing Office, November 1944
Subject(s):: Cold Temperature
Snow
Warfare
Military Science

60. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

Publication:: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017
Subject(s):: Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
Emergency Medical Services
Equipment Safety
Off-Label Use
Public Health
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Food and Drug Administration.

61. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

Publication:: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):: Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

62. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

63. Q3C--tables and list

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, [June 2017]
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Compounding -- standards
Solvents -- classification
Congresses as Topic
International Cooperation
Solvents -- adverse effects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

64. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Clinical Trials as Topic -- standards
Human Experimentation -- standards
Informed Consent -- standards
Ethics Committees, Research
Ethics, Research
Informed Consent -- ethics
Research Subjects
Risk
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

65. M4E(R2): the CTD--efficacy

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Drug Approval
Investigational New Drug Application
Drugs, Investigational
Clinical Trials as Topic
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

66. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Anti-Infective Agents, Local
Consumer Product Safety
Hand Sanitizers
Nonprescription Drugs
Anti-Bacterial Agents
Anti-Infective Agents, Local -- adverse effects
Soaps
Triclosan
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

67. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Drug Approval
Drug Industry -- standards
Drugs, Generic
Guideline Adherence
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

68. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

69. FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 29, 2017
Subject(s):: Device Approval
Small Business
Eligibility Determination
Taxes
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

70. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017
Subject(s):: Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
Data Collection
Data Interpretation, Statistical
Decision Making
Device Approval
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

71. Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 1, 2017
Subject(s):: Advisory Committees -- organization & administration
Device Approval
Equipment and Supplies -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

72. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017
Subject(s):: Equipment and Supplies -- standards
Equipment Design -- standards
Equipment Safety -- standards
Device Approval
Equipment Failure
Information Dissemination
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

73. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 12, 2017
Subject(s):: Clinical Trials as Topic
Demography
Device Approval
Research Design
Age Factors
Continental Population Groups
Ethnic Groups
Product Surveillance, Postmarketing
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

74. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017
Subject(s):: Device Approval
Papillomavirus Infections -- diagnosis
Reagent Kits, Diagnostic -- standards
Cervix Uteri -- cytology
Cervix Uteri -- virology
Equipment Failure
Equipment Safety
Genotyping Techniques -- standards
Mass Screening
Papillomaviridae -- classification
Papillomaviridae -- genetics
Quality Control
Reference Standards
Reproducibility of Results
Research Design
Specimen Handling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

75. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Sulfur
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

76. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
Infusions, Parenteral
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

77. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Drug Approval
Drug Contamination
Particulate Matter
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

78. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2010
Subject(s):: Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

79. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

80. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

81. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Capsules
Congresses as Topic
International Cooperation
Tablets
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

82. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Tablets
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

83. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
Electrophoresis, Polyacrylamide Gel
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

84. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Sterilization
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

85. Manual for public health nurses

Author(s):: Iowa. State Department of Health. Division of Public Health Nursing, author.
Publication:: [Des Moines] : State Department of Health, [1949?]
Subject(s):: Public Health Nursing
Nurses, Public Health
Iowa

86. Guidelines for the detection and management of lead poisoning for physicians and health care providers

Publication:: [Austin?] : Texas Dept. of Health, [1994]
Subject(s):: Lead Poisoning
Child
Infant

87. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

Publication:: Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017
Subject(s):: Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

88. Advancement of emerging technology applications for pharmaceutical innovation and modernization

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

89. Compliance policy for required warning statements on small-packaged cigars

Publication:: Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, September 2017
Subject(s):: Product Labeling -- standards
Product Packaging -- standards
Tobacco Products -- standards
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

90. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):: Device Approval -- standards
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

91. Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2017
Subject(s):: Device Approval -- standards
Communication
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

92. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):: Device Approval -- standards
Clinical Protocols
Research Design
Telecommunications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

93. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):: Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

94. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):: Data Display -- standards
Image Processing, Computer-Assisted -- standards
Radiology Information Systems -- standards
Device Approval -- standards
Product Labeling -- standards
Software -- standards
Technology, Radiologic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

95. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2017
Subject(s):: Documentation -- standards
Drug Approval
Congresses as Topic
European Union
International Cooperation
Pharmaceutical Preparations -- standards
Humans
Canada
Europe
Japan
Switzerland
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

96. The prohibition of distributing free samples of tobacco products

Publication:: Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, October 2017
Subject(s):: Commerce -- standards
Government Regulation
Tobacco Products -- supply & distribution
Tobacco Products -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

97. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017
Subject(s):: Device Approval -- standards
Equipment Design -- standards
Equipment Safety -- standards
Product Labeling -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

98. Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017
Subject(s):: Device Approval -- standards
Software -- standards
Computer Security
Equipment Design -- standards
Equipment Safety -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

99. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 30, 2017
Subject(s):: Classification
Device Approval -- standards
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

100. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, October 30, 2017
Subject(s):: Product Labeling -- standards
Ultrasonic Surgical Procedures -- instrumentation
Ultrasonic Surgical Procedures -- standards
Equipment Safety -- standards
Leiomyoma -- surgery
Suction -- instrumentation
Suction -- standards
Surgical Equipment -- adverse effects
Ultrasonic Surgical Procedures -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.