FDA Provides First Draft Guidance on REMS for Drugs, Biologics

The FDA has issued a draft guidance on risk evaluation and mitigation strategies (REMS) for drugs and biologics, sparking concerns from industry that it may add too much time to the approval process. “The industry’s key questions will include how much this will delay market growth,” Les Funtleyder, an analyst with Miller Tabak, said. The drug and biologics industries also will want to know how much it will cost companies to administer REMS and what penalties they will face if they don’t comply, Funtleyder added.
Drug Industry Daily