RAPS Highlights





15 October 2021 | By Michael Mezher
Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Merck's COVID drug

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

14 October 2021 | By Joanne S. Eglovitch
FDA nixes GUDID submission requirements for class I consumer healthcare devices

Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the U...

14 October 2021 | By Kari Oakes
Unanimous thumbs up from FDA committee for Moderna booster

An advisory committee to the US Food and Drug Administration (FDA) voted unanimously to recommend a half-strength booster dose of th...

14 October 2021 | By Michael Mezher
IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage

Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to...

14 October 2021 | By Nick Paul Taylor
Euro Roundup: EMA warns action against titanium dioxide will cause significant drug shortages

The European Medicines Agency (EMA) has found that requiring manufacturers to replace titanium dioxide (TiO2) in medicines “will alm...