Legislation

Preliminary registration data released by FDA offers a first glimpse of the Modernization of Cosmetics Regulation Act’s impact on information the agency has at hand.

FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.

“The president has chosen a do-it-all-now strategy, recognizing that the midterm congressional elections are a little over a year away,” says CHPA CEO Scott Melville. “We're just 57 days into the second Trump administration, and we are experiencing lots of unexpected things.”

CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.

Medicines for Europe’s director general described the directive as detrimental to the industry, patients, and the Commission’s ambitions to bolster the supply of critical medicines in the bloc as part of the Critical Medicines Act.

The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE.

2025 is likely to be a game-changing year for the pharmaceutical industry. Generics Bulletin sat down with Medicines for Europe’s Adrian van den Hoven and Beata Stepniewska to discuss the opportunities of the Critical Medicines Act and EU pharmaceutical legislation revision.

"While we mourn his passing, we also celebrate his remarkable legacy, which will continue to shape AHPA and the broader industry for years to come,” AHPA says.

Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.

Annette Dickinson was CRN’s original staff member when she helped form the group in 1973 and retired in 2005 after serving as president since 2003. CRN’s founders saw a need for "an association that was science-based, that took a rational approach to issues, that did not view regulators as necessarily the devil incarnate.”