Key House and Senate committees advanced reauthorizations of the Pandemic All-Hazards Preparedness Act. It is unclear whether new perks for the FDA and drug makers will survive as the two chambers reconcile a myriad of differences between their plans.
A Senate committee cleared a US Food and Drug Administration-requested pathogen preparedness program 20 July that is intended to help the agency avoid a repeat of the stress caused by the COVID-19 pandemic.
The Emerging Pathogen Preparedness Program Authorization Act, cleared the Senate Health, Education, Labor and Pensions Committee on a 12-9...
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
