USA – Rare diseases, STAR expansion considered in PDUFA VII premarket negotiations

Newly released minutes from meetings between industry and the US Food and Drug Administration (FDA) give observers more insight into premarket review issues in play during the negotiations for the reauthorization of the Prescription Drug User Fee Act (PDUFA VII).

FDA and industry looked at commitment language related to new molecular entity (NME) milestones and postmarketing requirements (PMR) in a 27 January meeting of the premarket negotiations subgroup. For both standard and priority NME new drug applications and original biological license applications, FDA is agreeing to formalize pre-approval communication timelines as commitments under PDUFA VII, rather than regarding these timelines as best practices.

The subgroup also discussed how to review existing (PMR) during the post-approval phase, considering timelines for release from PMR and what information FDA should include in its decision letters…