Competitive generic therapies: 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 Therapeutic Equivalency United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- The FDA Reauthorization Act of 2017, or FDARA, created a pathway by which FDA may, at the request of the applicant, designate a drug with “inadequate generic competition” as a competitive generic therapy (CGT). At the request of the applicant, FDA may also expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT. This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs. Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. This guidance revises the guidance of the same title issued in March 2020. This revision is being issued to incorporate information on the meeting types and performance goals included in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). 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 guidances 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 (i, 21 pages))
- NLM Unique ID:
- 9918504288406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918504288406676