Metal Hip Implants Face Tighter Controls

Wall Street Journal, January 18, 2013. Diana Zuckerman, president of the National Research Center for Women & Families, said: “There are so many shortcuts at the FDA device center that they often take a shortcut and approve a product with minimal safety testing.”

Read More »

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 »