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INDUSTRY LETTER

Third of a series of letters regarding the implementation of the Act March 1998

Download the Final Industry Letter
Final
Docket Number:
FDA-2011-D-0595
Issued by:
Guidance Issuing Office
Center 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.

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

 
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