FDA to Strengthen Impartiality of Advisory Committees
Criticism Over Advisory Committees Conflicts of Interest. Facing widespread criticism over potential conflicts of interest, the U.S. Food and Drug Administration (FDA) announced plans today to add stricter guidelines to its process of choosing advisory committee members. “FDA is committed to making the advisory committee process … [Read more...]
Patient Experiences to Become Part of Medical Device Reviews
The Food and Drug Administration (FDA) is developing guidelines that will incorporate patients’ experiences with medical devices into the regulatory review process. Working together, the Medical Device Innovation Consortium, a collaboration of the device industry, the FDA, and the National Institutes of Health, released a draft … [Read more...]
FDA Sunscreen Rules Could be Ready by Year’s End
Federal Regulators are Said to be Near Releasing New Guidelines for Sunscreens. After spending years promising to do so, federal regulators are said to be near releasing new guidelines for sunscreens. According to WebMD, the new sunscreen labeling rules should be finalized by the end of the year. More than 1 million Americans are … [Read more...]
Test Guidelines for New Defibrillator Criticized
Test Guidelines For a New Defibrillator. Dr. Robert Hauser of the Minneapolis Heart Institute Foundation has said in today’s New England Journal of Medicine that he is not confident in the test guidelines for a next-generation heart defibrillator under development by Medtronic, Inc., Boston Scientific Corporation, and St. Jude … [Read more...]
ATV Size Guidelines Put Kids at Risk
ATV Size Guidelines A Risk Of Injury. All terrain vehicle (ATV) size guidelines do not assure a proper fit, preliminary results from a new study suggest. These inadequate guidelines, researchers involved in the study say, put children who ride ATVs at a significant risk of injury. Even though they are used for recreation, ATVs … [Read more...]
Drug Coated Stent Guidelines Imminent, FDA Says
Drug Coated Stent developed as a way to keep blood vessels open after an angioplasty. Guidelines for the testing of drug coated stents are nearing publication, a Food & Drug Administration (FDA) official said yesterday. The FDA started working on the new drug coated stent guidelines amid concerns that the medical devices are more … [Read more...]
Hib Boosters Meningitis Vaccine Recall
Meningitis Vaccine Are Being Recalled. Hib vaccination guidelines where changed by the Centers for Disease Control (CDC) yesterday, and the agency is now recommending that children no longer be given a Hib booster. The CDC’s move was an attempt to head off a much-feared shortage of the meningitis vaccine following the Merck & Co. … [Read more...]
