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Lantheus NDA for Imaging Agent Accepted

[ Price : $8.95]

FDA accepts for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotre...

Senators Want Foreign Generic Drug Info

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Leaders of the Senate Special Committee on Aging ask executives of three group purchasing organizations a series of questions abou...

Hire Staff, Improve Morale, Cut INDs: Tidmarsh Goals

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New CDER director George Tidmarsh talks about hiring new reviewers, improving staff morale, and finding ways to safely speed drug ...

FDA Fast Track for Alphamab Cancer Drug

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FDA grants fast-track designation to Alphamab Oncologys JSKN003 to treat several cancers.

Court Finds Mifepristone REMS Unlawful

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A federal court ruling finds that FDA acted unlawfully by imposing certain REMS restrictions on mifepristone.

2 QSR Violations at Qinjiang Kingphar Medical

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FDA warns Chinas Qinjiang Kingphar Medical Material Co. about Quality System violations in its production of several medical devic...

FDA Drug Onshoring Policies Could Work: Attorneys

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Two Hyman, Phelps & McNamara attorneys report on the optimistic tone at a recent FDA public meeting on increasing U.S. drug manufa...

Multiple Violations Seen in Contec Medical Inspection

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FDA warns Chinas Contec Medical Systems about Quality System and Medical Device Reporting violations in its manufacturing of sever...

FDA Signals Pragmatic Push to Ease Biosimilar Development

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FDA Office of Therapeutic Biologics and Biosimilars director Sarah Yim says the agency is focused on making biosimilar development...