PhRMA, BIO, Amgen comment on REMS standardization

The Pharmaceutical Research and Manufacturers of America suggested FDA should use the same REMS templates and tools across products that share "similar risk profiles," starting with the standardization of prescriber tools. PhRMA said the move could reduce the burden on sponsors of user testing a variety of tools with similar goals. The recommendation came in comments PhRMA submitted to FDA that follow a July Amgen Inc. (NASDAQ:AMGN) also submitted comments to agency. All three reiterated support for developing a web portal where patients and healthcare providers could access REMS information online. PhRMA and BIO want FDA to study how continuing medical education programs could be used train physicians on the use of REMS. ...