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 ...

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

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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