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.

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All written comments should be identified with this document's docket number: FDA-2017-D-5868.