EMA Offers Free Early Dialogue For Anti-Bacterials, Anti-Fungals
The European Medicines Agency hopes that its early interaction service will help strengthen the drug development pipeline for new antimicrobials.
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Regulators involved in the EU Innovation Network are working on a pilot aimed at sponsors, who want to have an early dialogue on product development issues with a national competent authority in Europe, but also want to get other NCAs or innovation offices involved.
Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.
The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.