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INDUSTRY LETTER

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

Final
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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.