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RAPS Highlights





24 May 2022 | By Joanne S. Eglovitch
EMA releases final guideline on antibacterial drug development

The European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that is globally aligned wi...

24 May 2022 | By Gareth Macdonald
MDCG sets out transition periods for legacy diagnostics post-IVDR

The European Commission’s Medical Device Coordination Group (MDCG) has clarified how long legacy devices can remain on the market af...

24 May 2022 | By Nick Paul Taylor
Asia-Pacific Roundup: Philippine FDA seeks feedback on abridged procedures for clinical trial applications

The Philippine Food and Drug Administration (FDA) is planning to offer an abridged procedure for clinical trial applications by rely...

24 May 2022 | By Michael Mezher
Recon: Pfizer’s ulcerative colitis drug hits endpoints in Phase 3 trials; India’s Serum Institute plans new Africa plant

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

23 May 2022 | By Ferdous Al-Faruque
FDA takes steps to relax blood donor requirements

The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight o...