- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
This draft guidance describes the Food and Drug Administration's (FDA's or Agency) current thinking on recommended practices for drug manufacturers (firms) and their representatives to follow if they choose tp distribute to health care professional2 or health care entities3 scientific or medical journal articles that discuss new risk information for approval prescription drugs4, 5, 6 marketed in the United States.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-D-0758.