FDA Issues Guidance on Information Requests and Discipline Review Letters for Generics

The FDA has issued final guidance for industry explaining how the agency will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original abbreviated new drug application under the Federal Food, Drug and Cosmetic Act.

Titled Information Requests and Discipline Review Letters Under GDUFA, the guidance identifies the timing of FDA’s issuance of an IR or a DRL and the effect both documents will have on the assessment clock for a given assessment cycle.

The guidance finalizes the draft guidance of the same title issued on Dec. 18, 2017.

Read the notice here: www.fdanews.com/01-26-22-notice.pdf.