We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Rep. Rosa DeLauro (D-Conn.), the incoming chairwoman of the subcommittee with jurisdiction over the FDA’s budget, has a number of changes in mind for the agency, starting with an improved drug review system, the lawmaker says.
The FDA wants to create an electronic network to gather and share medical product safety information with healthcare professionals and patients, the agency announced.
The FDA has announced two major personnel changes, moving Janet Woodcock to oversee a new office and inserting John Dyer as deputy commissioner for operations and chief operating officer (COO) of the agency.
Rep. Rosa DeLauro (D-Conn.), the incoming chairwoman of the subcommittee with jurisdiction over the FDA’s budget, has a number of changes in mind for the agency, starting with an improved drug review system, the lawmaker says.
The FDA warned automatic external defibrillator (AED) maker MRL for several current good manufacturing practice (cGMP) violations and said the company's devices are adulterated and misbranded.
GE OEC Medical Systems, its parent company, General Electric (GE) — doing business as GE Healthcare — and two of GE’s top executives have signed an FDA consent decree of permanent injunction related to X-ray surgical imaging systems, the FDA said in a recent announcement.
After the FDA warned Tiara Medical Systems for several current good manufacturing practice violations regarding its complaint handling system, the company successfully responded to all charges, the agency said.
The FDA and the Centers for Medicare & Medicaid Services (CMS) need to base their product approvals and reimbursement decisions on more complete evidence when dealing with costly new technologies such as heart imaging devices, an expert says.
The FDA issued draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood for treatments for hematological malignancies.