Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in informed consent.
FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.
Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in informed consent.
FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.
The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is no proven cardiovascular benefit to using fenofibrates alone or with statins.
Dr. Reddy’s Laboratories recalls six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to decreased potency.
