- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This is the third in a series of letters intended to inform you of policy and procedure developments with respect to the implementation of the Drug Price Competition and Patent Restoration Act of 1984.
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-2011-D-0595.