Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
Milwaukee Journal Sentinel: The Case of BMP-2 Ignoring Any Benefit from…
Progress in medicine is essential for discovering new ways to make people healthier, experience less pain, and to live longer. The…
FDA Proposes Changes to Medical Device 510K Program
The Food and Drug Administration (FDA) issued preliminary recommendations for changes relating to the 510(k) program under which…
FDA and Disease Awareness Programs
Non product specific, non accredited education programs focusing on disease state awareness are one of the most recent additions…
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…
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…