BRIEF—Draft guidance published on information requests and discipline review letters under GDUFA

The US Food and Drug Administration (FDA) has published draft guidance on how it will issue and use information requests (IRs) and discipline review letters (DRLs) during the review of an original abbreviated new drug application under the Generic Drug User Fee Amendments of 2017.

IRs and DRLs are described the FDA as tools aimed at improving its predictability and transparency, promoting the efficiency and effectiveness of its review process, minimizing the number of review cycles necessary for approval and increasing overall approval rates, and facilitating greater access to generics.

The agency is  inviting comments on its draft guidance to be submitted by February 16.