FDA Outlines ANDA Reconsideration Procedures

The FDA has formalized its guidelines for sponsors seeking reconsideration of scientific or regulatory issues early in the approval process for generic drugs, issuing a guidance that also affirms the agency’s response-time pledges.

The pledges were included in the agency’s GDUFA II commitment letter negotiated with industry.

In the letter, the FDA said that if an applicant requests a teleconference as part of a request to reclassify a major amendment to an abbreviated new drug application or to a prior approval supplement, or of a request to reclassify the standard (non-priority) review status accorded an ANDA, PAS or amendments, the FDA will conduct the teleconference and decide 90 percent of the requests within 30 days.