Temporary policy on Prescription Drug Marketing Act requirements for distribution of drug samples during the COVID-19 public health emergency
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Prescription Drugs -- supply & distribution COVID-19 United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to address questions FDA has received asking for clarification regarding FDA's enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency (PHE). PDMA is part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the relevant implementing regulations regarding drug samples are in 21 CFR part 203 (part 203), subpart D.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (6 pages)).
- NLM Unique ID:
- 9918230602706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918230602706676