BRUSSELS @ EU regulators and notified body representatives said their organizations are evaluating the use of artificial intelligence (AI) for regulatory purposes but cautioned that the technology is ...

Learn how regulatory professionals can help shape trial design strategy working alongside clinical and statistical colleagues to accelerate timelines, reduce patient burden, and mitigate regulatory ...

India@s Central Drugs Standard Control Organization (CDSCO) has released draft revisions to guidance on biosimilar marketing authorization requirements for consultation. @ ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, ...

The Swiss Agency for Therapeutic Products (Swissmedic) has updated guidance on nitrosamines to clarify when new authorization applications must include a risk assessment. @ ...

This course provides an overview of the regulatory requirements for dietary supplements in the US and for NHPs in Canada.

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WASHINGTON, DC @ Despite the rapid changes happening at the US Food and Drug Administration (FDA), the Michelle Tarver, director of the Center for Devices and Radiological Health (CDRH), said the ...

An executive order signed by President Donald Trump on 24 April requires federal agencies to actively certify that a probationary worker would @benefit the federal service@ prior to their conversion ...

MedCon 2025 convened this week at the Hyatt Regency Columbus in Columbus, Ohio, welcoming 240 attendees from nine countries and four continents for three days of purpose-driven discussions.