Dr. Steven Galson, Director of the Center for Drug Evaluation and Research (CDER) at the FDA, recently announced a new "First Generics" policy for review of ANDAs. Under the agency’s current "First-In, First-Reviewed" policy, CDER reviews ANDAs in the order in which they are received. Under the new policy, FDA will make exceptions to the first-come, first-served approach in the following circumstances:
- an ANDA is received for a first generic (one that has never been approved, and that is not affected by blocking petitions or exclusivities);
- a public health emergency exists;
- a nationwide shortage of a drug exists;
- the ANDA is for a drug that falls under a special program, such as the President’s Emergency Plan for AIDS relief.
In these circumstances, CDER will endeavor to complete the ANDA review process within 6 months.
RELATED READING:
- Dr. Galson’s presentation at the GPhA Fall Technical Conference
- CDER’s "Review Order of Original ANDAs, Amendments, and Supplements" policy document
NOTE: thanks to Kurt Karst for passing along this news.
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