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GUIDANCE DOCUMENT

ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry November 2017

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2017-D-3101
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA) is issuing this revised draft guidance to describe the process through which prospective generic drug applicants seeking a priority review goal submit complete, accurate facility information in advance of submitting a priority original abbreviated new drug application (original ANDA), prior approval supplement (PAS), PAS amendment, or ANDA amendment (hereafter collectively referred to as ANDA).

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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-2017-D-3101.

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