Topic
FDA Approval
200 published works
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…
Mass Tort Litigation Blog
More FDA Fees, More Review
By joetort
Article in the Wall Street Journal -- FDA Change May Begin With User Fees, by Anna Wilde Mathews:The Food and Drug Administration's deal with the pharmaceutical industry about user fees…
PropertyProf Blog
AEI Conference: Is There a Constitutional Right to Medical Self-Defense?
By propertyprof
Here is the announcement from AEI:Start: Friday, December 8, 2006 12:15 PM End: Friday, December 8, 2006 2:00 PM Location: Wohlstetter Conference Center, Twelfth Floor, AEI1150 Seventeenth Street, N.W., Washington,…
Cam Law
FDA Attacks Continue
FDA attacks continue unabated over failure to adequately measure drug risks prior to new drug approval. Criticism of the FDA has been widely reported as of late. "Today, the Star…
Cam Law
FDA Advisory Panels Biased Toward Drug Approvals
The panels of experts assembled by the Food and Drug Administration to advise it on whether to approve new drugs and medical devices are often biased in favor of recommending…
TortsProf Blog
Other Presumption Ideas
Blog 702 raises a good question, citing my MIPR article [PDF]and presumably by implication my Point of Law piece on the same issue:Shouldn't those advocating such a presumption [for, for…
TortsProf Blog
A Right To Unapproved Drugs?
The DC Circuit apparently says so (summary, opinion [PDF]). I have not yet read the whole opinion; here's the introduction:The Abigail Alliance for Better Access to Developmental Drugs (“the Alliance”)…
Elder Law Prof Blog
UK: Alzheimer’s sufferers hit by further delay in NHS approval for vital drugs
From The Telegraph-UK:Thousands of Alzheimer's sufferers will have to wait until next year to learn if they will get vital drugs on the National Health Service.There was an angry response…
White Collar Crime Prof Blog
SEC Sues Biopure for False Statements About Pending Drug Approval
By Ellen Podgor
The SEC filed a securities fraud action against Biopure Corp., a biotech company, its former CEO, Thomas More, former senior VP Howard Richman, and current General Counsel, Jane Kober, related…