The Pink Sheet reports that pharmacist groups asked FDA to create a few common templates for risk evaluation and mitigation strategies so they can better anticipate and implement the programs into their practices.
FDA and industry groups spoke in favor of REMS templates July 27, the first day of a two-day agency workshop gathering comments on the program. FDA expects to use the comments to help formulate more guidance for REMS on drugs.
Janet Woodcock said an effort will begin in the fall to develop a standard REMS system.
"Each program is proposed by the drug sponsor and then it's negotiated between the sponsor and the FDA and is uniquely tailored to the risks of that particular drug," Woodcock said. "So we don't have the kind of standardization and consistency of the programs that would be ideal."
Additional REMS changes already have been proposed, including allowing medication guides to be developed outside the REMS process.
