FDA releases GDUFA draft guidance

SILVER SPRING, Md. — The Food and Drug Administration has released draft guidance for the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the agency said.

A collection of documents posted on the FDA's website includes guidance for the generic drug industry on self-identification of generic drug facilities, sites and organizations, questions and answers about the draft guidance and others.

The amendments, part of the renewal of PDUFA that president Barack Obama signed in July, will $299 million per year in user fees from generic drug companies over the next five years starting on Oct. 1. This, drug makers and agency officials hope, will help the FDA reduce a backlog of about 2,500 generic drug approval applications and ensure faster review of future applications.


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