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FDA Advisory Committees

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Latest From Advisory Committees

Genentech's Subcutaneous Rituximab Breezes Through US FDA Advisory Committee

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.

Advisory Committees Drug Review

The Politics Of Opana: US FDA’s Opioid Problems Won’t Go Away

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.

Advisory Committees FDA

US FDA Advisory Committee Drought Is Over … Unless Sponsors Are Scared Of Dark Clouds

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.

Advisory Committees Regulation

Subcutaneous Rituximab Seems Headed For US FDA Advisory Panel OK

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.

Advisory Committees Drug Review

Alka-Seltzer Antacid Will 'Plop, Plop Fizz, Fizz' Without Aspirin

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.

Consumer Drug Safety

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees
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