Topic
FDA Approval
198 published works
Biosimilars Law Blog
EMA regulatory approval changes for biosimilars on the horizon in the E.U.?
As mentioned in a previous post, the EMA set the standard for regulatory approval of biosimilars* with the adoption of their overarching general guideline in 2005 (CHMP/437/04 — PDF), followed…
Health Law Prof Blog
Michael Jackson’s Death Exposes Danger of Over-Broad Physician Prescribing Powers
This just in from Professor Jennifer S. Bard who will be returning as a guest blogger in the first part of the new year:A jury in California has imposed criminal responsibility for…
Reproductive Rights Prof Blog
FDA Advisory Panel Endorses Birth Control Patch Despite Higher Risk of Clots
Bloomberg: J&J Birth Control Patch Backed by FDA Advisory Panel Reviewing Clot Risks, by Anna Edney:Johnson & Johnson (JNJ)’s birth control patch won the backing of advisers to the U.S.…
Life Sciences Legal Insights
Recent Cases Raise Bar for Approving Generics
The Hatch-Waxman Act, a federal law passed in 1984, was designed to streamline the process for bringing generic drugs to market. Under the law, generic drug manufacturers may file an…
Chicago IP Litigation
ANDA Case Stayed Pending Reexam
Genzyme Corp. v. Cobrek Pharms., Inc., No. 10 C 112 (N.D. Ill. Feb. 17, 2011) (Dow, J.). Judge Dow used the Court's inherent power to grant plaintiff Genzyme's motion to…
Drug & Device Law
FDA Regulation and the Eye of the Beholder
Last week we got all misty-eyed about FDA, especially how it occasionally gets unfairly criticized by GAO. And then we got ornery about how plaintiff lawyers exploit such criticisms. As…
Reproductive Rights Prof Blog
FDA Approves Drug to Reduce Risk of Preterm Delivery
Chicago Tribune: FDA approves drug to reduce risk of premature births, by Andrew Zajac & Thomas H. Maugh II:The drug, a synthetic form of the hormone progesterone, is being marketed…
Reproductive Rights Prof Blog
Article Calls for FDA to Reconsider Age Restriction for Emergency Contraception
RH Reality Check: When Politics Trump Science Women Lose, by Emily Sullivan: After carefully considering her situation and making a personal decision, a young woman heads to her local pharmacy. …
Health Care and Life Sciences
FDA Announces Much Anticipated Public Hearing on Biosimilars
By Deborah M. Shelton Having had the opportunity to analyze the biosimilars provisions of the new health care law enacted this past March, stakeholders have at long last the chance…
Sixth Circuit Appellate Blog
En Banc Watch: Wyeth Asks for Rehearing En Banc on the Sixth Circuit’s Preemption Decision
As we reported earlier, Wyeth v. Wimbush was one of the first cases interpreting the Supreme Court’s decision in Wyeth v. Levine, and the first to extend Levine beyond failure…