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Two FDA advisory committees backed the removal of a black box label for Pfizer’s smoking cessation drug Chantix, citing the therapy’s risk-benefit ratio. Read More
The National Institute for Occupational Safety and Health is holding a public meaning on a testing protocol for universal closed system drug-transfer devices (CSTDs). Read More
A year from now, each drug product processed and moved through the U.S. supply chain could have its own unique identifier under the Drug Supply Security Act, FDA and industry officials said at a meeting Monday. Read More
The Regulatory Affairs Professionals Society has named longtime member Paul Brooks as its new executive director, effective Sept. 12. Brooks, an expert on medical device regulation, joins RAPS after a 35-year career at the British Standards Institution. Read More
The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends. Read More
The U.S. Department of Justice issued grand jury subpoenas to Taro Pharmaceuticals and two of the company’s senior officials over the pricing of its generics, the drugmaker revealed in an SEC filing. Read More