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ReconRecon
Recon: EMA recommends Regeneron, Celltrion antibodies; Ellume test recall expanded to 2M units
Posted 11 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions
Posted 21 October 2021 By Nick Paul Taylor
The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking fe...
RoundupsRoundups
Euro Roundup: PRAC starts reviewing risk of tumors linked to women’s health products
Posted 07 October 2021 By Nick Paul Taylor
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started reviewing the risk of tumors linked to women’s health products that contain nomegestrol or chlormadinone. PRAC opened the review in resp...
Regulatory NewsRegulatory News
MHRA floats overhaul of medical device regulation in public consultation
Posted 20 September 2021 By Nick Paul Taylor
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has advanced its effort to set up a post-Brexit regulatory environment by initiating a consultation on medical device regulation and establishing a work program for softwa...
Regulatory NewsRegulatory News
Convergence: Plenary probes how FDA, EMA will move forward
Posted 12 September 2021 By Kari Oakes
During the kickoff to RAPS Convergence 2021, leading regulators from the US and EU moved beyond the now-obligatory discussion of lessons learned from the pandemic to a substantive discussion of how the agencies are really faring a year a...
ReconRecon
Recon: EMA reviewing data on Pfizer booster shot; Roche, Adaptimmune sign $3B deal for off-the-shelf cell therapies
Posted 07 September 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Gruber and Krause to leave CBER; Sanofi refiles with FTC on $3.2B Translate Bio buyout
Posted 31 August 2021 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Pfizer, Moderna raise EU vaccine prices; FDA approves AZ’s lupus drug Saphnelo
Posted 02 August 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Books Books
Fundamentals of EU Regulatory Affairs, Ninth Edition (Hardcover)
Members: $295 Nonmembers: $395
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.