FDA seeking stakeholder input on REMS

FDA is holding a public meeting on July 25-26 to obtain stakeholder input on the agency's REMS program, including the issues and challenges associated with standardizing and assessing REMS. According to the meeting notice, the agency said it may establish standards to reduce "unnecessary variation" in REMS, though the agency noted that variations are sometimes appropriate to address "specific risks posed by particular drugs." FDA said it is aiming to make REMS more predictable and simpler to understand, implement and measure. ...