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INDUSTRY LETTER

Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format) March 1998

Download the Final Industry Letter
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This letter provides some information on how FDA intends to implement the Drug Price Competition and Patent Term Restoration Act.

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.

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