The US Food and Drug Administration (FDA) clarified in a final guidance dated 17 December that it will accept real-world evidence (RWE) without requiring identifiable patient-level data in medical ...

The US Food and Drug Administration (FDA) has finalized two guidances for sponsors and investigators regarding adverse event reporting for drugs, biologics, and medical devices in clinical studies.

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The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has finalized its revised guidance on running studies to show products are bioequivalent.

The third edition of Regulatory Intelligence 101 was developed for all regulatory professionals who generate regulatory intelligence, particularly those who deliver this key service to others in their ...

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Alongside the request for comments, HHS issued a separate notice identifying four documents for immediate recission, including a COVID-19 era notice on scarce or threatened materials subject to ...

Tweet Deck Once a premium tool, Twitter's purchase of Tweet Deck several years ago has opened it up to the masses, and with it a useful set of tools that should be of interest to anyone interested in ...

This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions @ EU, UK, US, China, and other regions of the world @ ...

The Department of Government Efficiency (DOGE) this week claimed it had canceled 30 leases for US Food and Drug Administration (FDA) facilities nationwide, including a facility in St. Louis, MO, which ...

While FDA experience is highly valued in the private industry, transitioning from the agency to private-sector employment requires new skills and a shift in mindset. This article provides resources ...

SILVER SPRING, MD @ Medtech industry stakeholders kicked off the latest round of medical user fee negotiations by stressing they want to ensure user fees supplement Congressionally appropriated ...