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6. Getting to the root of high prescription drug prices: drivers and potential solutions

Author(s):
Waxman, Henry, author
Corr, Bill, author
Martin, Kristi, author
Duong, Sophia, author
Publication:
[New York, N.Y.] : Commonwealth Fund, July 2017
Subject(s):
Cost Control
Drug Costs
Health Policy
Prescription Drugs -- economics
Drug Industry -- economics
Drugs, Generic -- economics
Economic Competition
Legislation, Drug
Orphan Drug Production -- economics
Humans
United States

8. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2017
Subject(s):
Emergency Medical Services -- legislation & jurisprudence
Emergency Responders -- legislation & jurisprudence
Pharmaceutical Preparations -- supply & distribution
Drug Therapy
Legislation, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

11. National Institutes of Health: Better data will improve understanding of federal contributions to drug development : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, April 2023
Subject(s):
Biomedical Research -- economics
Drug Development -- economics
Financing, Government -- organization & administration
Government Regulation
Health Occupations -- education
Legislation, Drug
United States
National Institutes of Health (U.S.)

13. 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

15. 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.

16. 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.

18. 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.

20. 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