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The overall number of pediatric patients prescribed antidepressants decreased nearly 10 percent after the FDA issued black box warnings two years ago, according to a therapeutic research organization.
The FDA has placed a rare clinical hold on a trial of gene therapy products after the sponsor, Atlanta-based Corautus Genetics,
reported three serious adverse events within 10 days.
Guidant in January 2005 chose not to alert physicians about electrical flaws in two heart defibrillators when the company knew of the defects, allowing patients to continue being implanted with the faulty devices, according to recently released documents.
A device used by Department of Veterans Affairs (VA) hospital centers may not have been delivered with complete instructions on cleaning and sanitizing the product after use, according to the VA.
Differences in the regulations for device trials as opposed to those for drugs can lead clinical sites into trouble if they do not understand those differences, said officials at a company currently conducting two Phase III investigational device exemption (IDE) trials.
A study released by the Centers for Disease Control (CDC) finds that patients taking stimulants for attention deficit hyperactivity disorder (ADHD) are making frequent trips to the emergency room amid a growing debate over the drugs' labeling.
Bristol-Myers Squibb (BMS) has discontinued development of muraglitazar after determining that the type 2 diabetes drug would take several more years to get FDA approval.