FDA Advisory Committees
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Advisory Committees
Lack of concerns about reformulation of product among either Oncologic Drugs Advisory Committee members or FDA reviewers and the decades-long existence of the molecules raises questions as to why the meeting was needed.
A two-day safety review of Endo’s reformulated Opana ER provided strong support for FDA’s view that products using abuse-deterrent technology cannot simply be assumed to be 'safer' than conventional formulations. However, there are also no easy answers for when and how FDA will be able to move out of the hot seat on opioid abuse.
FDA has three NDAs set for public advisory committee review at the end of March and early April, the first 'real' committee meetings in five months. Oops. Make that two.
Genentech used pharmacokinetic bridging studies for new route of administration, which uses the enzyme hyaluronidase and is strongly preferred by patients over the IV; firm is seeking indications for follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.
In advance of a US FDA advisory panel meeting on the safety of OTC monograph antacid/aspirin products, Bayer is removing aspirin from its pioneering Alka-Seltzer effervescent indigestion products. Bayer's Andre Schmidt talks about the safety advantages and consumer trends that helped spur the change.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You must sign in to use this functionality.
Please Sign In
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with active subscriptions will be able to access the full article. All other readers will be directed to the abstract and may purchase the article.