Subjects: Legislation, Drug / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Legislation, Drug ✖ Genre Guideline ✖

1. 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.

2. 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

3. 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

4. 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

5. Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
Subject(s):: Drug Industry
Legislation, Drug
Drug Packaging
Drug and Narcotic Control
Government Regulation
United States

6. 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.

7. Waivers, exceptions, and exemptions from the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Drug Industry
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration
United States.

8. DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Drug Industry
Government Regulation
Guidelines as Topic
Information Dissemination
Legislation, Drug
Prescription Drugs -- standards
United States

9. Reformulating drug products that contain carbomers manufactured with benzene: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Benzene
Drug Compounding
Drug Industry
Government Regulation
Legislation, Drug
Pharmaceutical Preparations
United States

10. Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Direct-to-Consumer Advertising -- legislation & jurisprudence
Drug Industry
Government Regulation
Legislation, Drug
Prescription Drugs
United States