Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act July 2014
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance document is intended to assist persons reporting drug sample distribution information2 to FDA under section 6004 of the Patient Protection and Affordable Care Act (ACA).
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-0829.