Articles related to REGULATORY AFFAIRS

HRSA’s revised 340B rebate pilot could require covered entities to purchase selected high-cost drugs at full price and recover discounts through manufacturer rebates beginning in 2027, prompting hospitals to evaluate data infrastructure, vendor readiness, and reimbursement workflows while legal and congressional challenges continue.

The FDA accepted Belite Bio’s NDA for tinlarebant in Stargardt disease type 1 and granted Priority Review. In the phase 3 DRAGON trial, treatment reduced atrophic retinal lesion growth by 35.7% compared with placebo, with regulatory review ongoing.

The FDA classified a voluntary nationwide recall involving nearly 12 million cartons of Rohto Cooling Eye Drops after a lack of assurance of sterility was identified. The action was designated a Class II recall, indicating medically reversible risks or a remote probability of serious harm.

A fatal cosmetic implant-removal procedure allegedly performed by an unlicensed individual promoted through social media has renewed attention on credential verification, patient safety, and online medical marketing. The case highlights regulatory and public safety concerns rather than new clinical evidence.

The FDA classified the nationwide recall of more than 2.5 million bottles of Lupin’s prednisolone acetate ophthalmic suspension as a Class II recall after reports of a foreign substance in affected products.

Ocular Therapeutix announced FDA alignment on a planned fourth-quarter 2026 NDA submission for Axpaxli in wet AMD, based on SOL-1 phase 3 efficacy data and interim safety results from the ongoing SOL-R trial.