Subjects: United States. Food and Drug Administration - Digital Collections - National Library of Medicine Search Results

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1. Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):: Device Approval
Equipment Safety
Morcellation -- adverse effects
Morcellation -- instrumentation
Product Labeling
Leiomyoma -- surgery
Uterine Neoplasms -- surgery
Humans
United States
United States. Food and Drug Administration

2. [A scientist uses a fast atomic bombardment mass spectrometer, which separates chemical components, at the FDA's Center for Biologics Evaluation and Research to determine the purity and potency of biologics and other products]

Publication:: [c1987]
Subject(s):: United States. Food and Drug Administration
Center for Biologics Evaluation and Research (U.S.)

3. Best practices for convening a GRAS panel: guidance for industry

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, December 2022
Subject(s):: Advisory Committees
Consumer Product Safety
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration

4. Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration

5. Recommendations to reduce the risk of transfusion-transmitted malaria: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2022
Subject(s):: Blood Banking -- methods
Blood-Borne Infections -- prevention & control
Government Regulation
Malaria -- prevention & control
Malaria -- transmission
United States
United States. Food and Drug Administration

6. Homeopathic drug products: guidance for FDA staff and industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
Subject(s):: Government Regulation
Homeopathy -- legislation & jurisprudence
Materia Medica
United States
United States. Food and Drug Administration

7. Pharmacokinetic-based criteria for supporting alternative dosing regimens of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for treatment of patients with cancer: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
Subject(s):: Government Regulation
Immune Checkpoint Inhibitors -- administration & dosage
Immune Checkpoint Inhibitors -- pharmacokinetics
Programmed Cell Death 1 Receptor -- administration & dosage
United States
United States. Food and Drug Administration

8. E19: a selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
Subject(s):: Clinical Trials as Topic
Data Collection
Government Regulation
Patient Safety
United States
United States. Food and Drug Administration

9. Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food, Drug, and Cosmetic Act: immediately in effect guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
Subject(s):: Anti-Bacterial Agents
beta-Lactams
Drug Compounding
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration

10. Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2022
Subject(s):: Government Regulation
Medical Device Legislation
Terminology as Topic
United States
United States. Food and Drug Administration
United States.

11. Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, November 2022
Subject(s):: Cell- and Tissue-Based Therapy
Clinical Trials as Topic
Genetic Therapy
Government Regulation
United States
United States. Food and Drug Administration

12. M10: bioanalytical method validation and study sample analysis : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
Subject(s):: Biological Products
Chemistry Techniques, Analytical
Government Regulation
Methods
United States
United States. Food and Drug Administration

13. Cross labeling oncology drugs in combination regimens: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
Subject(s):: Antineoplastic Combined Chemotherapy Protocols
Drug Labeling -- legislation & jurisprudence
Government Regulation
United States
United States. Food and Drug Administration

14. Surveying, leveling, and alignment laser products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health , January 31, 2023
Subject(s):: Government Regulation
Lasers
Medical Device Legislation
Weights and Measures
United States
United States. Food and Drug Administration

15. Cannabis and cannabis-derived compounds: quality considerations for clinical research : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
Subject(s):: Cannabis
Drug Development
Government Regulation
Medical Marijuana
United States
United States. Food and Drug Administration

16. Foreign supplier verification programs for importers of food for humans and animals: guidance for industry

Publication:: [Silver Spring, MD] : Office of Regulatory Affairs, January 2023
Subject(s):: Animal Feed -- standards
Animal Feed -- supply & distribution
Food Safety
Food Supply -- legislation & jurisprudence
Food Supply -- standards
Government Regulation
United States
United States. Food and Drug Administration

17. Format and content of a REMS document: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
Subject(s):: Biological Products
Consumer Product Safety -- legislation & jurisprudence
Drug Industry
Government Regulation
Risk Evaluation and Mitigation
United States
United States. Food and Drug Administration

18. Drug manufacturing: FDA should fully assess its efforts to encourage innovation : report to congressional committees

Publication:: Washington, DC : United States Government Accountability Office, March 2023
Subject(s):: Civil Defense -- legislation & jurisprudence
Drug Industry -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Pharmaceutical Preparations -- supply & distribution
Public Health -- legislation & jurisprudence
United States
United States. Food and Drug Administration

19. FDA oversight

Author(s):: White, Robert S., (Compliance attorney and member of the Oklahoma Bar), author
Publication:: [Toronto, Ontario] : Thomson Reuters, 19-December-2022
Subject(s):: Drug Approval -- legislation & jurisprudence
Government Regulation
Legislation, Drug
Drug-Related Side Effects and Adverse Reactions
Illicit Drugs
United States
United States. Food and Drug Administration

20. Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 22, 2022
Subject(s):: Device Approval
Government Regulation
United States
United States. Food and Drug Administration

21. Q3D(R2) elemental impurities

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Drug Contamination
Drug Industry
Elements
Government Regulation
Pharmaceutical Preparations -- standards
United States
United States. Food and Drug Administration

22. Policy for monkeypox tests to address the public health emergency: guidance for laboratories, commercial manufacturers, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 7, 2022
Subject(s):: Government Regulation
Monkeypox -- diagnosis
Monkeypox -- prevention & control
Public Health
Reagent Kits, Diagnostic
United States
United States. Food and Drug Administration

23. Submitting documents using real-world data and real-world evidence to FDA for drug and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Biological Products
Drug Development
Government Regulation
Pragmatic Clinical Trials as Topic
United States
United States. Food and Drug Administration

24. Tobacco products: principles for designing and conducting tobacco product perception and intention studies

Publication:: Silver Spring, MD : Center for Tobacco Products, August 2022
Subject(s):: Evaluation Studies as Topic
Government Regulation
Methods
Tobacco Products
United States
United States. Food and Drug Administration

25. Replacement reagent and instrument family policy for in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022
Subject(s):: Diagnostic Test Approval
Government Regulation
Reagent Kits, Diagnostic
United States
United States. Food and Drug Administration

26. Regulatory requirements for hearing aid devices and personal sound amplification products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022
Subject(s):: Device Approval
Government Regulation
Hearing Aids
United States
United States. Food and Drug Administration

27. Policy regarding N-acetyl-L-cysteine: guidance for industry

Publication:: College Park, MD : Center for Drug Evaluation and Research, August 2022
Subject(s):: Acetylcysteine
Drug Industry
Government Regulation
United States
United States. Food and Drug Administration

28. General clinical pharmacology considerations for neonatal studies for drugs and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration

29. Cancer clinical trial eligibility criteria: available therapy in non-curative settings

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Clinical Trials as Topic
Government Regulation
Neoplasms -- drug therapy
United States
United States. Food and Drug Administration

30. Orange Book: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration

31. Failure to respond to an ANDA complete response letter within the regulatory timeframe

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Correspondence as Topic
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration

32. Unique device identification: Policy regarding compliance dates for class I and unclassified devices, direct marking, and Global Unique Device Identification Database requirements for certain devices : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, July 25, 2022
Subject(s):: Databases as Topic
Equipment and Supplies
Government Regulation
Product Labeling
United States
United States. Food and Drug Administration

33. Instructions for use: patient labeling for human prescription drug and biological products : content and format

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Government Regulation
Prescription Drugs
Product Labeling
United States
United States. Food and Drug Administration

34. Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2022
Subject(s):: Administration, Oral
Drug Approval
Drugs, Investigational
Food-Drug Interactions
Government Regulation
United States
United States. Food and Drug Administration

35. Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022
Subject(s):: Diagnosis, Computer-Assisted
Device Approval
Government Regulation
Radiographic Image Interpretation, Computer-Assisted
United States
United States. Food and Drug Administration

36. Clinical decision support software: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 28, 2022
Subject(s):: Clinical Decision-Making
Decision Making, Computer-Assisted
Government Regulation
United States
United States. Food and Drug Administration

37. Exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Government Regulation
Legislation, Drug
Naloxone -- supply & distribution
Opioid Epidemic -- prevention & control
United States
United States. Food and Drug Administration

38. Competitive generic therapies: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration

39. Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Group Processes
United States
United States. Food and Drug Administration

40. Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration

41. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Device Approval -- legislation & jurisprudence
Government Regulation
Product Surveillance, Postmarketing
United States
United States. Food and Drug Administration

42. Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Clinical Studies as Topic
Device Approval
Government Regulation
United States
United States. Food and Drug Administration

43. Infant formula enforcement discretion policy: guidance for industry

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, May 2022
Subject(s):: Food Supply -- legislation & jurisprudence
Government Regulation
Infant Formula -- legislation & jurisprudence
United States
United States. Food and Drug Administration

44. Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Capsules -- standards
Drugs, Generic -- standards
Government Regulation
Tablets -- standards
United States
United States. Food and Drug Administration

45. S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
Subject(s):: Carcinogenicity Tests -- standards
Drug Evaluation, Preclinical
Government Regulation
United States
United States. Food and Drug Administration

46. Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps): small entity compliance guide : guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, November 2022
Subject(s):: Biological Products -- standards
Government Regulation
United States
United States. Food and Drug Administration

47. Human gene therapy for neurodegenerative diseases: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2022
Subject(s):: Clinical Studies as Topic
Genetic Therapy -- legislation & jurisprudence
Government Regulation
Neurodegenerative Diseases -- therapy
United States
United States. Food and Drug Administration

48. Refusal of inspection by a foreign food establishment or foreign government: guidance for industry

Publication:: [Silver Spring, MD] : Office of Regulatory Affairs, October 2022
Subject(s):: Federal Government
Food Inspection -- legislation & jurisprudence
Food Safety
Government Regulation
Refusal to Participate
United States
United States. Food and Drug Administration

49. Multiple endpoints in clinical trials: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biostatistics
Clinical Trials as Topic
Endpoint Determination
Government Regulation
United States
United States. Food and Drug Administration

50. Laboratory accreditation for analyses of foods: what you need to know about the FDA regulation : guidance for industry : small entity compliance guide

Publication:: Rockville, MD : Center for Food Safety and Applied Nutrition, October 2022
Subject(s):: Food Analysis -- legislation & jurisprudence
Food Safety
Government Regulation
Laboratories
Legislation, Food
United States
United States. Food and Drug Administration