FDA MDR rule speaks plainly
This article was originally published in The Gray Sheet
Direct final rule to translate FDA's medical device reporting rule into plain language will become effective July 13, FDA confirms. The agency received 16 comments, including letters from NEMA and AdvaMed, urging it to make revisions to the MDR reg before moving forward with the final rule (1"The Gray Sheet" May 30, 2005, p. 6). However, FDA has decided to implement the plain language modifications as initially proposed in February. FDA "did not receive any significant comment on the plain language revisions," FDA explains in the Federal Register notice...
You may also be interested in...
FDA should withdraw its medical device reporting direct final rule and "proceed with the usual procedures for notice and comment on the companion proposed rule," NEMA asserts in a May 12 FDL-1letter to the agency
Teva plans to begin appeal proceedings, the firm has told Generics Bulletin, after being fined €60.5m ($72m) by the European Commission over an historic “pay-for-delay” arrangement covering subsidiary firm Cephalon’s Provigil (modafinil).
SK set for Korean trial with vaccine, as Biological E begins human trials of Baylor vaccine. Meanwhile, DongWha gets a Phase II nod for potential drug, and Celltrion progesses with Phase II regdanvimab trial.