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FDA
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…
Top Three Diabetes Organizations Issue Physician Guidance on Avandia and CV…
After an FDA external advisory panel last week provided mixed recommendations regarding Avandia (rosiglitazone), the American…
FDA REMS: Continuing Medical Education Requirement for Malaria Drug
Last week, the Food and Drug Administration (FDA) imposed a Risk Evaluation and Mitigation Strategy (REMS) on AR Scientific…
FDA Avandia Hearing Update – Committee Votes Increased Risk of CV events,…
After almost two days of rigorous debate, the time for the FDA vote on the fate of Avandia is upon us.
The 33 member FDA advisory…
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 – PDUFA Monthly Meetings Beginning July 1, 2010
The statutory authority for the Prescription Drug User Fee Act (PDUFA) is set to expire in September 2012. At that time, new…
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…