FDA releases the proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act, outlining changes to drug review, manufacturing oversight, regulatory science programs and the structure of industry fees.
Foundation for Prader-Willi Research warns that real-world reports of edema and other serious heart and respiratory problems among patients taking Neurocrine’s Vykat XR have prompted recommendations for closer monitoring of some patients.
FDA releases the proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act, outlining changes to drug review, manufacturing oversight, regulatory science programs and the structure of industry fees.
Foundation for Prader-Willi Research warns that real-world reports of edema and other serious heart and respiratory problems among patients taking Neurocrine’s Vykat XR have prompted recommendations for closer monitoring of some patients.
The Department of Justice seeks an injunction to stop Steiner Biotechnology from manufacturing and marketing adulterated and misbranded dental medical devices that have been subject to FDA warnings for seven years.
FDA is raising questions about the risk/benefit of ADC Therapeutics’ Zynlonta as a second-line treatment for diffuse large B-cell lymphoma.
