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GUIDANCE DOCUMENT

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

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Guidance for Industry 180-Day Exclusivity: Questions and Answers

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

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.