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2. 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.

3. 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.

4. 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.

5. 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.

7. 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.

8. 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.

9. 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.

11. 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.

16. Preliminary report on the vaccination of man against equine encephalomyelitis (western type)

Author(s):
United States. Neurotropic Virus Disease Commission, author, issuing body.
Publication:
[Washington, D.C.] : Neurotropic Virus Diease Commission of the Board for the Investigation of Epidemic Disease in the Army, [1942?]
Subject(s):
Encephalomyelitis, Equine -- prevention & control
Vaccination
Viral Vaccines
Clinical Trials as Topic
World War II

18. 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.

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

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2017
Subject(s):
Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Cardiotoxins
Clinical Trials as Topic
Congresses as Topic
Diagnosis, Computer-Assisted
Drug-Related Side Effects and Adverse Reactions
International Cooperation
Pharmaceutical Preparations -- administration & dosage
Reference Standards
Research Design
Sex Factors
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

21. 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.

22. 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.

23. Palliative care in the outpatient setting: a comparative effectiveness report : final report

Author(s):
Cunningham, Courtney, author
Trevers, Karin, author
Chapman, Rick, author
Loos, Anne, author
Lawler, Erin, author
Liu, Shanshan, author
Pearson, Steven D., author
Ollendorf, Daniel A., author
Publication:
Boston, MA : Institute for Clinical and Economic Review, April 27, 2016
Subject(s):
Ambulatory Care -- organization & administration
Comparative Effectiveness Research
Palliative Care -- organization & administration
Anxiety -- therapy
Caregivers
Clinical Trials as Topic
Cost Savings
Cost-Benefit Analysis
Depression -- therapy
Health Policy
Health Resources -- utilization
Health Services Accessibility
Healthcare Disparities
Insurance, Health, Reimbursement
Medicaid -- economics
Medicare -- economics
Outcome Assessment (Health Care)
Palliative Care -- manpower
Patient Education as Topic
Patient Satisfaction
Quality of Life
Research
Spirituality
Humans
United States

25. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
Antiviral Agents -- pharmacokinetics
Drugs, Investigational -- pharmacokinetics
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

26. Recurrent herpes labialis: developing drugs for treatment and prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Drugs, Investigational -- therapeutic use
Herpes Labialis -- drug therapy
Herpes Labialis -- prevention & control
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

28. An evidence-based health care system: the case for clinical trials registries : Office of Medical Applications of Research, National Institutes of Health [and] National Library of Medicine, Lister Hill Auditorium, Bethesda, Maryland, December 6-7, 1993

Author(s):
NIH Technology Assessment Workshop (1993 : Bethesda, Md.)
Publication:
[Bethesda, Md. : Office of Medical Applications of Research?, 1993]
Subject(s):
Information Systems
Clinical Trials as Topic
Evidence-Based Medicine -- methods
Registries

31. Chimeric antigen receptor T-cell therapy for B-cell cancers: effectiveness and value : final evidence report

Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, March 23, 2018
Subject(s):
Immunotherapy, Adoptive
Leukemia, B-Cell -- drug therapy
Lymphoma, B-Cell -- drug therapy
Lymphoma, Non-Hodgkin -- drug therapy
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Adult
Child
Clinical Trials as Topic
Clofarabine -- therapeutic use
Cost-Benefit Analysis
Immunotherapy, Adoptive -- adverse effects
Immunotherapy, Adoptive -- economics
Receptors, Chimeric Antigen -- therapeutic use
Treatment Outcome
Humans
United States

32. Modulator treatments for cystic fibrosis: effectiveness and value : final evidence report and meeting summary

Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, June 7, 2018
Subject(s):
Cystic Fibrosis -- drug therapy
Cystic Fibrosis Transmembrane Conductance Regulator -- therapeutic use
Clinical Trials as Topic
Cost of Illness
Cost-Benefit Analysis
Cystic Fibrosis Transmembrane Conductance Regulator -- adverse effects
Treatment Outcome
Humans
United States

33. Calcitonin gene-related peptide (CGRP) inhibitors as preventive treatments for patients with episodic or chronic migraine: effectiveness and value : final evidence report

Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, July 3, 2018
Subject(s):
Calcitonin Gene-Related Peptide Receptor Antagonists -- therapeutic use
Migraine Disorders -- drug therapy
Migraine Disorders -- prevention & control
Calcitonin Gene-Related Peptide Receptor Antagonists -- adverse effects
Chronic Disease
Clinical Trials as Topic
Treatment Outcome
Humans
United States

34. Targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis: effectiveness and value : condition update : final evidence report

Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, August 3, 2018
Subject(s):
Immunologic Factors -- therapeutic use
Immunomodulation
Psoriasis -- drug therapy
Certolizumab Pegol -- therapeutic use
Clinical Trials as Topic
Cost-Benefit Analysis
Immunologic Factors -- adverse effects
Immunologic Factors -- economics
Quality of Life
Treatment Outcome
Humans
United States

35. Inotersen and patisiran for hereditary transthyretin amyloidosis: effectiveness and value : final evidence report

Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, October 4, 2018
Subject(s):
Amyloidosis, Familial -- drug therapy
RNA, Small Interfering -- therapeutic use
Amyloid Neuropathies, Familial -- drug therapy
Amyloidosis, Familial -- complications
Clinical Trials as Topic
Cost-Benefit Analysis
RNA, Small Interfering -- adverse effects
RNA, Small Interfering -- economics
Treatment Outcome
Humans
United States

36. Implantable devices: regulatory framework and reform options

Author(s):
Lind, Keith D., author
Publication:
Washington, DC : AARP Public Policy Institute, August 2017
Subject(s):
Government Regulation
Prostheses and Implants -- adverse effects
Prostheses and Implants -- standards
Clinical Trials as Topic
Device Approval
Equipment Failure
Equipment Safety
Product Surveillance, Postmarketing
Registries
Humans
United States
United States. Food and Drug Administration.

44. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Breast Neoplasms
Clinical Trials as Topic
Neoadjuvant Therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

45. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:
Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

47. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

48. Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

49. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:
Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):
Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

51. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):
Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

52. Enhancing the diversity of clinical trial populations: eligibility criteria, enrollment practices, and trial designs

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):
Biological Variation, Population
Clinical Trial Protocols as Topic
Clinical Trials as Topic
Population Characteristics
Cultural Diversity
Genetic Variation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

55. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022
Subject(s):
Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

56. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022
Subject(s):
Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

57. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
Subject(s):
Clinical Trials as Topic
Device Approval
Drug Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

59. Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):
Drug Interactions
Clinical Trials as Topic
Cytochrome P-450 Enzyme System
Drugs, Investigational
Membrane Transport Proteins
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

62. Human gene therapy for hemophilia

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):
Genetic Therapy
Hemophilia A -- drug therapy
Hemophilia B -- drug therapy
Clinical Trials as Topic
Drug Evaluation, Preclinical
Factor VIII -- therapeutic use
Factor IX -- therapeutic use
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

64. Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):
Antineoplastic Agents
Biological Products
Clinical Trials as Topic
Drug Development -- legislation & jurisprudence
Drug Development -- standards
Medical Oncology
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

65. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):
Antineoplastic Agents
Biological Products
Clinical Trial Protocols as Topic
Clinical Trials as Topic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

67. Opioid use disorder: developing depot buprenorphine products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2019
Subject(s):
Buprenorphine -- therapeutic use
Drug Development
Opioid-Related Disorders -- drug therapy
Buprenorphine -- administration & dosage
Clinical Trials as Topic
Delayed-Action Preparations
Narcotic Antagonists
Opiate Substitution Treatment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

68. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Clinical Trials as Topic
Prognosis
Research Design
Biomarkers, Pharmacological
Biomarkers, Tumor
Captopril -- therapeutic use
Cardiovascular Diseases -- drug therapy
Clozapine -- therapeutic use
Cyclooxygenase 2 Inhibitors -- therapeutic use
Drugs, Investigational
Lung Diseases -- drug therapy
Medication Adherence
Neoplasms -- drug therapy
Patient Compliance
Patient Selection
Pharmacogenetics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

69. Pediatric HIV infection: drug product development for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Development -- standards
HIV Infections -- drug therapy
Pediatrics
Adolescent
Anti-Retroviral Agents -- therapeutic use
Child
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

70. Human immunodeficiency virus-1 infection: developing systemic drug products for pre-exposure prophylaxis

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Development
HIV Infections -- prevention & control
Pre-Exposure Prophylaxis
Adolescent
Child
Clinical Trials as Topic
HIV Infections -- drug therapy
HIV-1
Infant
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

71. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):
Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
Endpoint Determination
Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy
Leukemia, Myeloid, Acute -- drug therapy
Leukemia, Promyelocytic, Acute -- drug therapy
Multiple Myeloma -- drug therapy
Patient Selection
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Prognosis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

72. Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):
Administration, Topical
Drug Approval
Nonprescription Drugs
Absorption, Physiological
Clinical Trials as Topic
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

73. Considerations in demonstrating interchangeability with a reference product

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):
Biosimilar Pharmaceuticals -- standards
Drug Substitution
Proteins -- therapeutic use
Biological Products
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

74. Premarket tobacco product applications for electronic nicotine delivery systems

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, June 2019
Subject(s):
Device Approval -- legislation & jurisprudence
Electronic Nicotine Delivery Systems -- standards
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

76. Delayed graft function in kidney transplantation: developing drugs for prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):
Delayed Graft Function -- drug therapy
Drug Development -- standards
Kidney Transplantation
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

77. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019
Subject(s):
Clinical Trials as Topic
Device Approval
Data Collection
Ethics Committees, Research
Informed Consent
Single-Case Studies as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

80. Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Anticonvulsants -- therapeutic use
Clinical Trials as Topic
Drug Development -- standards
Seizures -- drug therapy
Adolescent
Anticonvulsants -- pharmacology
Child
Child, Preschool
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

81. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

Publication:
Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019
Subject(s):
Clinical Trials as Topic
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

82. Smallpox (variola virus) infection: developing drugs for treatment or prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):
Clinical Trials as Topic
Drug Development -- standards
Smallpox -- drug therapy
Smallpox -- prevention & control
Antiviral Agents -- pharmacology
Antiviral Agents -- therapeutic use
Drug Evaluation, Preclinical
Emergencies
Investigational New Drug Application
Models, Animal
Orthopoxvirus
Public Health
Research Design
Safety
Toxicity Tests
Variola virus
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

85. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

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