5 July 2021 - This project has been established to enhance the adverse event reporting processes. ...
21 June 2021 - The US FDA "may require” or seek agreement from sponsors to conduct post-marketing studies to analyse ...
10 September 2019 - Often times when a new drug is approved by the FDA, the agency requires more studies be ...
16 November 2018 - The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As ...
24 May 2018 - Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at ...
7 December 2017 - Under various circumstances, the FDA may require a drug maker to run a post-marketing study, but ...
7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be ...
19 May 2017 - New medicines that win U.S. marketing approval without conclusive evidence of their effectiveness aren't always proven ...
15 May 2017 - Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research ...
10 February 2017 - EU PAS Register increases transparency of research in medicines after they have been authorised in the ...
4 July 2016 - The EMA has concluded its second inquiry within the framework of its infringement procedure against Roche. ...