FDA Outlines ANDA Reconsideration Procedures

October 13, 2017

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.

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