News dal mondo

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US FDA Launches Pilot To Expedite INDs

FDA has launched a pilot program to expedite review of investigational new drug (IND) filings with applications for the pilot due by October 30. It is part of the agency’s Operation TrialBlazer initiative, designed to make the US more competitive in early-stage research....[DCAT]

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EU Biotech ACT - Ue in ritardo sui farmaci biotech, sempre più ampio il gap con USA

È quanto emerso in un incontro svolto nei giorni scorsi a Bruxelles tra alcuni parlamentari europei...

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Innovation & Pharma: The Molecules & Companies

How truly innovative is the bio/pharma industry? What products, modalities, and companies are behind...

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EDQM - Update to the guidance for electronic submissions of CEP applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated the guidance PA/PH/CEP...