FDA Opioid REMS: ACPE Outlines Pharmacists Role in Education
During last month’s Joint Meeting of the Anesthetic and Life Drugs Advisory Committee (ALSDAC) & Drug Safety and Risk…
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Food and Drug Administration
FDA: Warning Letters May Double in 2010
A recent article in MM&M highlighted how warning letters (found here) sent by the Food and Drug Administration’s (FDA)…
FDA Opioid REMS Advisory Panel Focus on CME for Improving Practice
As we noted last week, Murray Kopelow, M.D., M.S., Chief Executive and Secretary for the Accreditation Council for Continuing…
FDA Pain REMS Advisory Committee to Include Presentations on Continuing…
Today, Murray Kopelow, M.D., M.S., Chief Executive and Secretary for the Accreditation Council for Continuing Medical Education…
FDA Avandia Hearing Update – Committee Votes to Keep Avandia on the Market…
The FDA advisory panel on Avandia voted in favor of keeping Avandia (rosiglitizone) on the market the vote breaks down as…
FDA Direct to Consumer Proposed Rule: Advertising Coalition’s Response
The Advertising Coalition recently sent comments to the Food and Drug Administration (FDA) in response to a Notice of Proposed…
FDA Turns to CME for Risk Evaluation and Mitigation Strategy (REMS) Pain…
According to a FDA memo and recent article in the RPM Report, “continuing medical education (CME) has been under attack in…
FDA Proposed Rule on Falsification of Data
For years, the Food and Drug Administration (FDA) has acknowledged that “falsification of data can, if not detected, undermine…
FDA: Off Label May Be the Wrong Label
The Food and Drug Administration (FDA) has acknowledged for years that "good medical practice and the best interests of the…
IOM: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
In 2008, the Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to conduct a study on the evaluation…