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In August, the FDA will release a long-awaited multicenter analysis of current good manufacturing practices (cGMPs), according to acting FDA Commissioner Lester Crawford.
The FDA has referred Elan Pharmaceuticals’ Zonegran, GlaxoSmithKline’s (GSK) Wellbutrin and Zyban and GelTex Pharmaceuticals’ Renagel to the Foundation for the National Institutes of Health (NIH) for pediatric studies that potentially could lead to new labeling for relevant pediatric populations.
The Office of the U.S. Trade Representative has appointed an assistant U.S. trade representative for pharmaceutical policy, marking the agency’s entry into the debate over reimportation and price controls.
An Indianapolis, Ind., grand jury has indicted a California couple for fraudulently obtaining nearly $1.5 million worth of diabetic test strips from Roche Diagnostics.
Medtronic has voluntarily recalled two older models of implantable cardiac defibrillators (ICDs) — the MicroJewel II model 7223Cx and Gem DR model 7271 — after receiving reports of four patient deaths and one serious injury that may have been related to a charging problem in the ICDs.
Automatic external defibrillator (AED) manufacturer Cardiac Science has been warned by the FDA for corrective and preventive action (CAPA) violations at its Minneapolis, Minn., plant.
The FDA has warned a Canadian device firm for a faulty medical device reporting (MDR) system and failure to report at least six serious injuries and device malfunctions.
The FDA has accused a Florida audiometry firm of manufacturing devices without an established quality system (QS) or medical device reporting (MDR) procedures as required by the agency to ensure the public's health and safety.
The future of the FDA’s Center for Devices and Radiological Health (CDRH) will be focused on meeting the goals established by the Medical Device User Fee and Modernization Act (MDUFAMA), said the center’s new acting director Dan Schultz
An FDA advisory panel voted April 21 to support approval of a new carotid artery stent system, but the narrow outcome of the vote suggested that concerns remain over the device's use in low-risk patients.