Topic
FDA Approval
198 published works
Reproductive Rights Prof Blog
FDA Grants Priority Review of Cervical Cancer Vaccine For Adult Women
Reuters: FDA grants fast review of Gardasil for adult women (3/19):Merck & Co on Wednesday said U.S. regulators have granted apriority review for the company's application to expand marketing ofits…
Mass Tort Litigation Blog
FDA Drug Approval Near Deadline Linked to Safety Problems
By joetort
Article in the Wall Street Journal -- Late Drug Approval Linked To Safety Issues, by Keith J. Winstein. Here's an excerpt:Although every unsafe drug is different, most of them have…
TortsProf Blog
Is the FDA Tougher Than Its European Counterpart?
Today's Wall Street Journal includes an interesting article by Jeanne Whalen comparing the FDA's approval process for new drug applications with the European process:It is unclear whether getting FDA approval…
TortsProf Blog
“Drug Approved. Is the Disease Real?”
That's the provocative title of Alex Berenson's article today covering the recent FDA approval of Lyrica's new indication for fibromyalgia. As the story notes, some researchers are not convinced that…
Reproductive Rights Prof Blog
Newly Appointed Acting Surgeon General Played Role in Holding Up OTC Sale of Emergency Contraception
Via Our Bodies, Our Blog:Dr. Steven Galson, former Director of the FDA's Center for Drug Evaluation and Research (the agency's drug review and approval arm), has been appointed to the…
Mass Tort Litigation Blog
Increased FDA Scrutiny of Legacy Drugs
By joetort
Editorial in the Wall Street Journal -- The FDA vs. Small Pharma. Here's an excerpt:Western Europeans began using quinine as a medicine in the 17th century. Then again, they didn't…
Drug & Device Law
Abigail Alliance: Tempest In A Teapot?
By Bexis
We’re thinking about the recent Abigail Alliance case again. As readers of this blog know, the en banc D.C. Circuit held on August 7 that terminally ill patients do not…
TortsProf Blog
A Couple of Zyprexa Developments
In what sounds like an approvable letter for Symbyax (which is a fixed dose combination of Zyprexa and Prozac), the FDA (via Pharmalot) expressed concern about the safety data disclosed…
Mass Tort Litigation Blog
FDA Position Makes More Difficult Approval of Merck’s Arcoxia
By joetort
Article in the Wall Street Journal -- FDA's Position on New Drugs May Hurt Merck's Arcoxia Bid, by Jennifer Corbett Dooren. Here's an excerpt:The Food and Drug Administration said proposed…
Mass Tort Litigation Blog
Questionable MDS Tests and Drug Approval Applications to FDA
By joetort
Article in the Wall Street Journal -- MDS Tests Are at Center Of FDA Query, by Jennifer Corbett Dooren:The Food and Drug Administration is asking all drug companies that have…