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Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry
Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Approval
Drugs, Generic
Government Regulation
Group Processes
United States
United States. Food and Drug Administration - Genre(s):
- Guideline
Technical Report - Abstract:
- This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) for a complex product, as defined in this guidance. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, mid-cycle review meetings (MCRMs), enhanced mid-cycle review meetings (EMCRMs), and post-complete response letter (CRL) scientific meetings with FDA. This guidance reflects a unified approach to formal meetings between FDA and prospective ANDA applicants or ANDA applicants for complex products under the pre-ANDA program and the ANDA assessment program. This guidance will assist applicants in generating and submitting to FDA a meeting request and the associated meeting package for complex products, as defined in this guidance, that are or will be the subject of ANDAs submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C 355(j)), and as contemplated in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This guidance revises the guidance of the same title issued in November 2020. This revision is being issued to incorporate information on the complex product meeting types and performance goals included in the GDUFA III commitment letter, including information on requesting these meetings and FDA’s procedures for handling these meetings. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (32 pages))
- NLM Unique ID:
- 9918504288506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918504288506676