FDA REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is… Thomas Sullivan Apr 22, 2019 0 Recently the FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and…
CME FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for… Thomas Sullivan Jul 9, 2012 0 After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies…
CME FDA REMS: Blue Print for Prescriber Continuing Education Program for… Thomas Sullivan Nov 8, 2011 0 The Food and Drug Administration (FDA) released a “Blueprint for Prescriber Continuing Education Program” regarding the use of…
ACCME ACCME: Changes to Complaint Process, Knowledge Based CME, and New Call for… Thomas Sullivan Aug 13, 2010 0 The Accreditation Council of Continuing Medical Education (ACCME) announced a number of important topics in their recent August…
CME FDA Opioid REMS: ACPE Outlines Pharmacists Role in Education Thomas Sullivan Aug 4, 2010 0 During last month’s Joint Meeting of the Anesthetic and Life Drugs Advisory Committee (ALSDAC) & Drug Safety and Risk…
ACCME FDA Opioid REMS Advisory Panel Focus on CME for Improving Practice Thomas Sullivan Jul 27, 2010 0 As we noted last week, Murray Kopelow, M.D., M.S., Chief Executive and Secretary for the Accreditation Council for Continuing…
CME FDA Turns to CME for Risk Evaluation and Mitigation Strategy (REMS) Pain… Thomas Sullivan Jul 8, 2010 0 According to a FDA memo and recent article in the RPM Report, “continuing medical education (CME) has been under attack in…
FDA FDA: Off Label May Be the Wrong Label Thomas Sullivan May 27, 2010 0 The Food and Drug Administration (FDA) has acknowledged for years that "good medical practice and the best interests of the…
FDA Five Part Podcast Series on FDA Features John Kamp of Coalition for… Thomas Sullivan Feb 18, 2010 0 A new five-part Podcast series was recently announced by Med Ad News editors Steven Niles and Joshua Slatko. The series will…
FDA FDA Announces Strategic Plan for Risk Communication Thomas Sullivan Oct 1, 2009 0 The FDA today announced a Strategic Plan for Risk Communication that establishes a framework for communicating meaningful health…