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New CDER director George Tidmarsh talks about hiring new reviewers, improving staff morale, and finding ways to safely speed drug ...[ Price : $8.95]
FDA grants fast-track designation to Alphamab Oncologys JSKN003 to treat several cancers.[ Price : $8.95]
A federal court ruling finds that FDA acted unlawfully by imposing certain REMS restrictions on mifepristone.[ Price : $8.95]
FDA warns Chinas Qinjiang Kingphar Medical Material Co. about Quality System violations in its production of several medical devic...[ Price : $8.95]
Two Hyman, Phelps & McNamara attorneys report on the optimistic tone at a recent FDA public meeting on increasing U.S. drug manufa...[ Price : $8.95]
FDA warns Chinas Contec Medical Systems about Quality System and Medical Device Reporting violations in its manufacturing of sever...[ Price : $8.95]
FDA Office of Therapeutic Biologics and Biosimilars director Sarah Yim says the agency is focused on making biosimilar development...