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The expanded HHS mandate that clinical trial investigators publish their full results on ClinicalTrials.gov is backed up with strong consequences for non-compliance that will be enforced by the FDA and the National Institutes of Health. Read More
The FDA is turning up the heat on pharmaceutical firms for a range of GMP violations, firing off warning letters to three companies over issues ranging from data integrity to risk management. Read More
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