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GUIDANCE DOCUMENT

Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry October 2017

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry

Docket Number:
FDA-2017-D-5868
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations for industry on the procedures for resolving scientific 16 and/or regulatory issues or matters between FDA and applicants of abbreviated new drug 17 applications (ANDAs) that wish to pursue a request for reconsideration within the review 18 discipline at the division level or original signatory authority. This guidance does not describe 19 the formal dispute resolution procedures for resolving scientific and/or regulatory disputes 20 between FDA and sponsors or applicants that cannot be resolved through the request for 21 reconsideration process at the division level.2 This guidance also does not describe the 22 procedures for resolving administrative matters, such as disputes regarding user fee 23 assessments.


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:

Division of Dockets Management (HFA- 305)
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-5868.