Topic
FDA Approval
198 published works
Reproductive Rights Prof Blog
Expanded Access Expected with New One-Dose Version of Emergency Contraception
Reuters (7/13): UPDATE 1-New Teva emergency contraceptive to expand market: ...Israel-based Teva, the world's biggest generic drug company,and Hungarian drug maker Richter Gedeon GDRB.BU said on Mondaythe U.S. Food and…
Reproductive Rights Prof Blog
FDA Approves Access to Emergency Contraception for 17-Year-Olds
NY Times: 'Morning After' Pill Cleared for 17-Year-Olds, by Gardiner Harris: Seventeen-year-olds will soon be allowed to buy morning-aftercontraceptive pills without a doctor’s prescription after federal drugregulators complied with a…
Mass Tort Litigation Blog
Wall Street Journal on Provenge & the FDA
By joetort
Editorial in today's Wall Street Journal on the delay in approving prostate-cancer drug Provenge by the FDA -- Prostate Cancer and FDA Politics: Their first priority should be to save…
Marler Blog
Denis Stearns – Guest Blogger – The Dissenting Justices in Wyeth v. Levine on the FDA-Approval of Drugs: “Is it Safe?”
By Bill Marler
In reading Justice Alito’s dissent in Wyeth v. Levine, the recent Supreme Court opinion holding that FDA-approval does not provide a complete defense to state law failure-to-warn claim, I was…
Administrative and Regulatory
Time for a basic change in FDA approval process?
By Ken Shigley
Time to streamline FDA approval process and devise a uniform federal process for drug and medical device liability?
Health Industry Washington Watch
Certifications of Clinical Trial Registry/Results Submissions; Final Guidance
The FDA has released final guidance on “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII…
Mass Tort Litigation Blog
GAO Criticizes FDA
By joetort
The New York Times reports that the Government Accountability Office recently criticized the Food and Drug Administration's device approval process. Here's an excerpt:Created in 1976, the F.D.A.’s process for approving…
Health Industry Washington Watch
FDA Guidance: Bioequivalence (BE) Recommendations and Drug Clinical Trials
The FDA has announced the availability of additional draft and revised draft product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). FDA will accept comments…
The Right Coast
I want a new drug Tom Smith
I want this drug even though I am not a mouse. I can't make myself go to the gym every day, but I bet I could take a pill every…
Securities Law Prof Blog
SEC Settles Fraud Charges Against Former Transkaryotic Therapies CEO
The SEC announced that on July 9, 2008, a final judgment by consent was entered by the United States District Court Judge for the District of Massachusetts against Richard F.…