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FDA
Update on Risk Evaluation and Mitigation Strategies
For many years, we have written about the authority granted to the FDA from the 1997 Food and Drug Administration Amendments Act…
FDA Pushes Back Release of Generic Drug Safety Label Rules
The United States Food and Drug Administration (FDA) has once again pushed back the release of a final rule allowing…
FDA Agency Update December 2015
As 2015 comes to a close for the FDA, it remains an agency in transition. The agency should soon see a new commissioner…
Amarin Update – The Case of Many Cases
There are currently two cases working their way through the legal system relating to Amarin and their quest for exclusivity and…
Pacira Update: A Settlement in the Works?
As we have previously written, the FDA has recently removed the Pacira warning letter from their website, which set off a…
FDA Establishes the Patient Engagement Advisory Committee
There has been a surge in the development of new medical technologies over the last couple of decades. When looking at the way…
FDA Notice of PDUFA Reauthorization – Public Comments due April 29, 2016
The Food and Drug Administration has issued a notice that they are reopening the comment period for interested parties to submit…
White House Nominates Robert Califf As The Next FDA Commissioner
President Barack Obama has nominated the Food and Drug Administration's Dr. Robert Califf, the current Deputy Commissioner for…
Be Careful What You Wish For? FDA’s Biosimilars Naming Guidance Proposes…
Yesterday, the Food and Drug Administration (FDA) released much anticipated guidance on how they plan to address nonproprietary…
FTC Urges FDA To Reevaluate Current Approach To Regulating Homeopathic…
Last week, the Federal Trade Commission (FTC) recommended that the Food and Drug Administration (FDA) consider…