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The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies. Read More
The FDA is simplifying the process of developing written procedures for an IRB, providing industry with a comprehensive checklist that satisfies both FDA and HHS requirements. Read More
Better communication with states is needed when the FDA stops a drug compounder from operating, the agency said in a new set of recommendations. Read More
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