Guidance Helps Generics Industry Submit Better Apps

FDA says a recent guidance on Good ANDA Submission Practices helps generic drug manufacturers obtain faster approvals by submitting more complete ANDA applications. A 2/6 CDER Small Business and Industry Assistance podcast says that until now, half of all ANDAs with GDUFA review goals required at least three review cycles to reach approval or tentative approval, which CDER says is an inefficient and resource-intensive process.

“The new guidance lists common, recurring deficiencies that may lead to a delay in the approval of an ANDA, such as issues with patents and exclusivities, labeling, product quality, and bioequivalence,” the podcast says. “It also provides recommendations to applicants on how to avoid these deficiencies. The goal is to minimize the number of cycles necessary for approval.”

The podcast contains 14 recommendations for ANDA sponsors to follow in hopes of preventing applicant submission deficiencies.