- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This guidance does not describe the formal dispute resolution procedures for resolving scientific and/or regulatory disputes between FDA and sponsors or applicants that cannot be resolved through the request for reconsideration process at the division level. This guidance also does not describe the procedures for resolving administrative matters, such as disputes regarding user fee assessments.
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:
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.