Regulatory

The MHRA’s premarket statutory instrument for Great Britain should to be laid before UK parliament in Q2 and be in force by year end, in an ideal world. There are concerns that the new statutory instrument must align with imminent EU MDR changes.

The company will exclude data from patients at the “small number” of sites that experienced irregularities and enroll new patients in their place.

CRN’s attorneys ask Second Circuit for en banc review of a three-judge panel’s denial of its appeal of 2024 decision in district court rejecting motion for preliminary injunction against enforcement of New York state law age-restricting sales of weight loss and muscle building supplements.

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.

International reliance mechanisms for approving drugs have an important place, but the UK regulator should increase focus on becoming a first approver of medicines, according to the British pharmaceutical industry.

With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.

Under the newly-announced UK-US trade deal, the UK will increase the thresholds used to evaluate the cost-effectiveness of new medicines, which should allow higher prices for innovative therapies.

France is set to pilot a new fast-track process that could more than halve the timeline for authorizing certain clinical trial applications.

Generics Bulletin reviews global regulatory developments across the world.

Approval of numerous Rx formulations hasn’t translated to wider availability when a remedy is needed for anaphylaxis emergency, say FDA and the Margolis Institute in announcing workshop on reducing anaphylaxis-related morbidity and mortality.

Argentina’s medicines regulator, ANMAT, is updating the national pharmacopeia with new guidelines on advanced therapies.

A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.