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.
US FDA Gets Wanted Pathogen Program, Manufacturers Get Longer BARDA Contracts In Competing Pandemic Prep Bills
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.
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Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
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Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
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The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
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Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.