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Guidance for Industry 180-Day Exclusivity: Questions and Answers January 2017


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to address questions that have been raised about the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic drug exclusivity, which commonly is known as 180-day exclusivity for generic drug products. As a general matter, the Food and Drug Administration (FDA or the Agency) has implemented these statutory provisions within the context of application-specific decisions.

Submit Comments

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-2016-D-4645.

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