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FDA
FDA Receives Input on Prescription Drug User Fee Act Reauthorization 2012
The Food and Drug Administration (FDA) periodically conducts meetings on the Prescription Drug User Fee Act (PDUFA) program. The…
Generic Manufacture CEO Banned from Working in Industry – FDA Enforcement
Last month, Food and Drug Administration (FDA) Deputy Chief for Litigation Eric Blumberg told Bloomberg news that, “Drugmaker…
Vermont Data Mining Law Struck Down – Next Stop Supreme Court?
A recent opinion from the United States Court of Appeals for the First Circuit concluded that a Vermont law, which banned data…
How Conflict of Interest Rules Endanger Medical Progress and Cures
Over the past several years, pharmaceutical and device companies have been facing significant legal and regulatory challenges that…
FDA Bad Ad Program – The End of Trust?
This summer, the Food and Drug Administration (FDA) launched “The Bad Ad Program,” which is designed to educate health care…
FDA – DTC Advertising Format Variations Study
The Food and Drug Administration (FDA) announced an opportunity for the public to comment on the Experimental Study of Format…
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…