FDA Seeks Comments on Transparency and Communication for New Entities
The Food and Drug Administration (FDA) recently announced an opportunity for public comment on the statement of work for an…
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Food and Drug Administration
FDA: Recently Signed PDUFA 5 Provisions to Address Drug Shortages
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which gives…
FDA: Food and Drug Administration Safety and Innovation Act (FDASIA) and…
Last week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). Among the numerous…
FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for…
After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies…
The Cultivating Scientific Expertise to Foster Innovation for Patients Act…
As we noted last week, a group of bipartisan Senators including Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael…
Par Pharmaceuticals vs. FDA Calling for Truthful Speech vs. FDA Approved
Last June, the United States Supreme Court, in a landmark decision, invalidated a Vermont law, which tried to restrict commercial…
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…
Allergan Botox Settlement and Corporate Integrity Agreement
This week, the United States Department of Justice (DOJ) announced that it has reached a resolution regarding the previously…
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 and Disease Awareness Programs
Non product specific, non accredited education programs focusing on disease state awareness are one of the most recent additions…