This on-demand webinar is FREE.
The FDA offers priority review to abbreviated new drug applications (ANDAs) that may have meaningful impact on generic drug access. Priority review means that FDA gives an ANDA submission either (1) a shorter goal date, or (2) an expedited review. For an ANDA submission to be eligible for priority review, it must meet one of the criteria for one of several public health priorities — known as prioritization factors — identified by FDA in MAPP 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (“Prioritization MAPP”). Office of Generic Drugs Regulatory Counsel David Coppersmith, JD, will review recent revisions to this MAPP.
- The January 2020 revision to MAPP 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements, which describes how the review of original abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements are prioritized for review by the Office of Generic Drugs and the Office of Pharmaceutical Quality.
- Detailed descriptions of the revisions including:
- Requests for Priority Review
- Submissions for Drug Products with Not More than Three Approved Drug Products
- Applications Containing a Paragraph IV Certification
- Submissions for Which Final Approval Is Dependent on the Expiration of a Patent or New Drug Application Exclusivity
- Submissions for Sole Source Drug Products
- How this MAPP supports the Drug Competition Action Plan, which seeks to expand access to safe, high quality, effective generic medicines that can help consumers lower their health care costs.
- Regulatory affairs professionals working on ANDAs, amendments, and supplements
- Consultants assisting applicants and potential applicants for ANDAs, amendments, and supplements
- Media and trade press
David Coppersmith, JD
Policy | Office of Generic Drugs | CDER | FDA
- MAPP 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements
- FDA’s Drug Competition Action Plan
For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707
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