Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry October 2022
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
his guidance provides recommendations to industry on post-complete response letter (CRL) teleconferences (post-CRL clarification teleconferences) between FDA and abbreviated new drug application (ANDA) applicants for the purpose of clarifying deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance is intended to provide procedures that will promote well-managed post-CRL clarification teleconferences and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).
This guidance revises the guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA issued in December 2018. This revision is being issued to incorporate the performance goals outlined in the GDUFA III commitment letter that FDA has agreed to meet, and clarifies how FDA will conduct post-CRL clarification teleconferences subject to the GDUFA performance goals.
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-5928.