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Start Over Subjects Legislation, Drug ✖Remove constraint Subjects: Legislation, Drug Languages English ✖Remove constraint Languages: English

12. 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

14. A sense of déjà vu: the debate surrounding state biosimilar substitution laws

Author(s):
Purvis, Leigh, author
Publication:
Washington, D.C. : AARP Public Policy Institute, September 2014
Subject(s):
Biological Products -- economics
Biological Products -- therapeutic use
Biosimilar Pharmaceuticals -- economics
Biosimilar Pharmaceuticals -- therapeutic use
Drug Costs
Drug Substitution
Legislation, Drug
Drugs, Generic -- economics
Federal Government
State Government
Humans
United States
United States. Food and Drug Administration.
United States.

15. Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):
Legislation, Drug
Legislation, Food
Marketing -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

17. Providing regulatory submissions for medical devices in electronic format: submissions under Section 745A(b) 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, July 15, 2020
Subject(s):
Electronic Data Processing -- legislation & jurisprudence
Legislation, Drug
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Drug safety: COVID-19 complicates already challenged FDA foreign inspection program : testimony before the Committee on Finance, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, June 2, 2020
Subject(s):
Pharmaceutical Preparations -- supply & distribution
Drug Contamination -- legislation & jurisprudence
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration