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 ...

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, ...

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 ...

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BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device regulation (MDR). The new NB designation—the ...

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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 ...

The European Medicines Agency (EMA) is proposing to waive comparative efficacy studies (CES) for biosimilars with a straightforward mechanism of action (MOA), such as monoclonal antibodies and ...