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FDA Commissioner Mark McClellan could be in the running to lead the Centers for Medicare & Medicaid Services (CMS) — a critical position in the Bush administration’s efforts to institute far-reaching changes in the Medicare program, which includes prescription drug benefits approved by Congress last year.
The FDA is broadening the regulatory scope of its tissue products regulations to include heart valves and dura mater, which have been traditionally regulated as devices by the agency.
Devicemakers who do not meet with the FDA prior to filing an expedited premarket approval (PMA) application could face significant review delays, according to Thinh Nguyen, director of the premarket approval application program in the Office of Device Evaluation.
Devicemakers do not have to substantially revise ISO 13485-compliant quality management systems (QMS) to meet the FDA's quality system regulation (QSR) because the standard does not set up conflicting requirements, according to David Feigal, director of the Center for Devices and Radiological Health (CDRH).
Even though HHS has stated that the Medicare Rx drug law does not give the secretary the power to approve pilot plans sponsored by state and local governments, and the FDA has repeatedly opposed the reimportation of prescription drugs, the agency continues to meet with state and local officials to clear up confusion over the practice.
The address for the Central Documents Room for filing Drug Master File (DMF) updates has changed, according to the Center for Drug Evaluation and Research.
The FDA continued its battle to stop the illegal importation of prescription drugs from Canada yesterday, issuing a warning letter to a pharmacy benefits manager, insurance company and claims processor.
Antidepressants like Prozac, Zoloft and Paxil do not raise the risk of suicide in children, a group of U.S. researchers said in a report released just weeks before an FDA advisory panel is scheduled to discuss safety concerns about the drugs.