FDA to Tweak Pre-Submission Draft Guidance for GDUFA II

August 24, 2017

The FDA will revise existing pre-submission draft guidance for ANDAs in light of the passage of the FDA Reauthorization Act of 2017.

The law, signed by President Donald Trump last week, includes provisions to speed up review for certain ANDAs by allowing “pre-submission” of some information ahead of the application.

The agency announced it will review priority original ANDAs, amendments and prior approval supplements no later than eight months after submission if the applicants provide pre-submission correspondence two months ahead of the ANDA and that correspondence is complete and accurate and no major changes are made before the ANDA submission, according to the goals letter for GDUFA II.

The agency will give companies the option to pre-submit ANDA sections that contain key data on clinical sites, bioequivalence, manufacturing facilities and organizations.

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