BRIEF—US FDA publishes GDUFA III guidance

The US Food and Drug Administration has  published more information related to recent changes to Generic Drug User Fee Amendments (GDUFA).

The guidance comes after the US Congress voted to reauthorize the relevant legislation, at the end of September.

Known as GDUFA III, the new provisions are already in effect, and are valid through 30 September 2027.

The latest information published by the FDA includes  changes to the user fees payable by generic drugmakers, as well as an  update to the process for submitting abbreviated new drug applications (ANDA).