FDA Beat, December 4, 2012. Discussions during an advisory committee review Janssen’s TB drug bedaquiline showed some interesting thinking around accelerated approval and how much uncertainty can be acceptable—especially when it comes to safety. Yttri warned called “approval of drugs based on the promise of benefit” a “dangerous practice.”
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
No Need for Skin Preps to Be Sterile, FDA Told
MedPage Today, December 13, 2012. Requiring that antiseptic skin preparation products be sterile — a standard not currently mandated by the FDA — is unnecessary and wouldn’t produce a dramatic drop in infections, manufacturers, clinicians, and policy analysts told the FDA Wednesday. “We need to have better communication that a product is not sterile,” Dr. Jennifer Yttri said, adding that could come from product labeling.
Read More »Allergan Drops Bid for FDA Approval to Promote Lap-Band for Teens
LA Times, October 3, 2012. The maker of the Lap-Band weight-loss device, Allergan Inc., has dropped its controversial bid for federal approval to market the product for overweight teens. Doctors already can perform Lap-Band surgery on minors with parental consent. The FDA approval would have allowed Allergan to market Lap-Band specifically for younger people.
Read More »F.D.A. Bans BPA From Baby Bottles and Sippy Cups
The New York Times, July 17, 2012. The FDA bans bisphenol A in baby bottles and children’s drinking cups.
Read More »Johnson & Johnson Unit to Halt Urinary Implants
New York Times, June 6, 2012. Johnson and Johnson halts production of mesh urinary implants due to lawsuits and many women who were harmed by the devices.
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