FDA Announces New "First Generics" Policy for Review of ANDAs

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.