Topic
FDA Approval
198 published works
Health Industry Washington Watch
Parallel CMS/FDA Review of Medical Products
On September 17, 2010, CMS and FDA published a notice announcing that they are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor…
Reproductive Rights Prof Blog
5-Day Emergency Contraceptive Approved by F.D.A. for Prescription Only
NY Times: F.D.A. Approves 5-Day Emergency Contraceptive, by Gardiner Harris: WASHINGTON — Federal drug regulators on Friday approved a new form of emergency contraceptive pill that prevents pregnancies if taken…
Health Law Prof Blog
FDA Advisory Panel Nixes “Pink Viagra”
Flibanserin is a drug under consideration by the FDA for the treatment of Hypoactive Sexual Desire Disorder in women. An FDA advisory panel voted 10 to one that flibanserin was…
Reproductive Rights Prof Blog
Panel Recommends Approval of After-Sex Contraceptive Pill
NY Times: Panel Recommends Approval of After-Sex Pill, by Gardiner Harris: GAITHERSBURG, Md. — A federal advisory panel voted unanimously Thursday that federal drug regulators should approve a medicine that…
Reproductive Rights Prof Blog
FDA Says “Female Viagra” Performed Poorly in Studies
Salon.com: "Female viagra" leaves FDA unsatisfied, by Tracy Clark-Flory:Studies fail to prove that the so-called "pink pill" can fix women's sex drive The feverish excitement over a "female Viagra" prototype has…
Dangerous Drugs & Medical Devices
FDA Launches New Website To Show Safety Information Of New Drugs
This is a great step towards greater transparency: WASHINGTON — The Food and Drug Administration launched a website Tuesday where patients and health care professionals can find safety information about…
Reproductive Rights Prof Blog
New Emergency Contraceptive Pill Prompts Debate
Wash. Post: New 'morning-after' pill, ella, raises debate over similarity to abortion drug, by Rob Stein: A French drug company is seeking to offer American women something their European counterparts…
Drug & Device Law
Managing the Michigan Diaspora
By Bexis
We haven’t heard the folks on the other side say it much, since ATRA’s pretty much taken over squatter’s rights to the phrase “Hellhole Jurisdiction,” but if they listed theirs,…
California Personal Injury Law Case Notes
FDA’s Role In Approving Yaz and Yasmin Examined
The legal talk show Lawyer2Lawyer invited Mike Danko and an FDA expert, Professor James T. O'Reilly from the University of Cincinnati College of Law, to discuss Yaz and the Yaz lawsuits. …
Health Industry Washington Watch
Drugs Approved on the Basis of Surrogate Endpoints
This post was written by Paul Sheives. FDA is authorized to approve applications based on clinical trials that demonstrate a new drug’s impact on a “surrogate endpoint,” or laboratory measure…