Real-world evidence in advertising CONTEXT: A very interesting opinion piece on the implications of the increased role of real-world evidence (RWE) in the pharmaceutical industry. The article lays out the Continue Reading
Implications of the upcoming changes to French ATU (Autorisation Temporaire d’Utilisation) programme CONTEXT: From July of 2021manufacturers will be required to make all early access authorisation requests to the HAS Continue Reading
Cures 2.0 – Details of what’s in store for Real-World Evidence CONTEXT: This article provides a nice summary and a bit more detail on the draft legislation that will eventually Continue Reading
Unexpected, but welcome, inclusion in Cures 2.0 of provision for real-world evidence in evaluation of safety and efficacy of pharmaceutical products. CONTEXT: The follow-up to the U.S 21st Century Cures Continue Reading
CONTEXT: As promised, we will keep you up to date on the FDA guidance on RWE in pediatric oncology. It seems the guidance will be available soon, but following a Continue Reading
CONTEXT: Big news in the world of Big data. When Action, Flatiron Health, IQVIA, Syapse and Tempus all get together to form a coalition with the aim of promoting RWE Continue Reading
CONTEXT: EMA and DG SANTE have signed a confidentiality agreement with ANVISA | Announcement of a new partnership between EU and Brazilian Regulatory Authorities to further develop mutual recognition and Continue Reading
CONTEXT: An august meeting of medical societies in Brussels to debate a few interesting topics for our discerning readers | Firstly the implications of the new IVD regulations which are definitely Continue Reading
CONTEXT: Commercial announcement of a significant acquisition in the RWD space | Is this the biggest deal we will see this year or is there more to come? IMPACT: Medium Continue Reading
CONTEXT: Opinion piece on where the author sees the FDA being focused through this next year. IMPACT: Low READ TIME: 2 mins Quality Level Mean [1 – 10]: 6 1. Continue Reading
