REMS – Policy & Medicine

REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary — Final Guidance

FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for Extended Release/Long Acting Opioids Including a Prescriber Education Program

FDA REMS: Blue Print for Prescriber Continuing Education Program for Extended Release-Long Acting Opioids

ACCME: Changes to Complaint Process, Knowledge Based CME, and New Call for Comment

FDA Opioid REMS: ACPE Outlines Pharmacists Role in Education

FDA Opioid REMS Advisory Panel Focus on CME for Improving Practice

FDA Turns to CME for Risk Evaluation and Mitigation Strategy (REMS) Pain Education

FDA: Off Label May Be the Wrong Label

Five Part Podcast Series on FDA Features John Kamp of Coalition for Healthcare Communication

FDA Announces Strategic Plan for Risk Communication