regulatory

MEET US AT ISO TECHNICAL COMMITTEE 194 MEETING – BERLIN (GERMANY)

4 - 6 Dec 2018
Meditrial will participate as Expert at the ISO Technical Committee 194 Meeting in Berlin on December 4-6,2018.

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FDA New Guidance on Trial Meta-Analyses

Sponsors will have to plan carefully — and show their work — if they want to use meta-analyses to prove drugs are safe, the FDA says in new draft guidance..

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Clinicaltrials.gov: Beware of Penalties!

The US Food and Drug Administration (FDA) is proposing heavy fines for pharmaceutical companies that fail to...

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