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Examining how well medical device companies engage with patients in clinical trials is becoming part of the new normal at the FDA, say agency officials. Read More
A federal judge halted sales by a California company that customizes dietary supplements by name and formulation until the company clears an FDA inspection. Read More
The European Medicines Agency will try to maintain “business as usual” for as long as possible throughout the U.K.’s upcoming exit from the European Union, according to a newly released continuity plan. Read More
The agency said sponsors should take any necessary additional steps ahead of pediatric studies, depending on nonclinical pharmacology and toxicology findings observed in adults. Read More
Rather than replacing relationships between the FDA’s product centers and patient organizations, the committee aims to expand those connections. Read More