FDA publishes a guidance with recommendations for manufacturers on information to go in premarket submissions for radiological devices with quantitati...
The Alliance for a Stronger FDA says it supports the FDA funding proposed by a House Agriculture Appropriations subcommittee.
The American Medical Association calls on FDA to approve a switch of hormonal oral contraceptives from prescription to over-the-counter status.
CDER director Patrizia Cavazzoni praises accomplishments in the generic drug program during Covid-19.
FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have ...
FDA warns Smitha Reddy and her Poway, CA-based ACRC Studies facility about objectionable conditions in conducting two clinical investigations.
FDA warns Deerfield Beach, FL-based Hybrid Pharma about multiple violations in its work as an outsourcing facility.
FDA approves an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection once every three mon...