Leaders of the Senate Special Committee on Aging ask executives of three group purchasing organizations a series of questions about vulnerabilities in...
New CDER director George Tidmarsh talks about hiring new reviewers, improving staff morale, and finding ways to safely speed drug approvals.
FDA grants fast-track designation to Alphamab Oncologys JSKN003 to treat several cancers.
A federal court ruling finds that FDA acted unlawfully by imposing certain REMS restrictions on mifepristone.
FDA proposes a major shift in how biosimilars are evaluated, signaling that many products may no longer need traditional comparative clinical efficacy...
FDA warns Chinas Qinjiang Kingphar Medical Material Co. about Quality System violations in its production of several medical devices.
Two Hyman, Phelps & McNamara attorneys report on the optimistic tone at a recent FDA public meeting on increasing U.S. drug manufacturing.
