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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects United States. ✖Remove constraint Subjects: United States. Genre Guideline ✖Remove constraint Genre: Guideline

11. 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.

12. Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
Subject(s):
Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.

13. Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
Subject(s):
Administration, Oral
Drug Compounding -- methods
Drug Compounding -- standards
Drug Industry
Government Regulation
Ibuprofen
Legislation, Drug
Suspensions
United States
United States. Food and Drug Administration
United States.

18. 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.

19. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.