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FDA
FDA Updates 510K Approval Process for Medical Devices
This week, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced new actions for the…
FDA Transparency Initiative: Improving Transparency to Regulated Industry
In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to help…
FDA to Hold MDUFA Meetings
The Food and Drug Administration (FDA) will be holding its first patient and consumer advocacy group meeting on the…
FDA Transparency Guidance — Advisory Committees
The Food and Drug Administration’s (FDA’s) advisory committees play an essential role in FDA’s activities to protect and promote…
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…