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Generic drug "variations" guidance will extend ANDA "collapsibility," FDAer says.

This article was originally published in The Tan Sheet

Executive Summary

GENERIC DRUGS "VARIATIONS" GUIDANCE WILL EXTEND ANDA COLLAPSIBILITY to all dosage forms contained within a single abbreviated drug approval application, FDA Division of Labeling and Program Support Deputy Director Robert West reported at a Regulatory Affairs Professionals Society conference in Newark, N.J. April 3. Approximately 65% of all ANDAs submitted to the agency's Office of Generic Drugs are covered by current policy. The upcoming guidance, due by year end, will provide collapsibility criteria for the remaining 35%, West said.

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