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WLF Claims Win In Lexapro Case Dismissal

[ Price : $8.95]

Washington Legal Foundation says the 2nd Circuit Court of Appeals upheld the dismissal of a case against Forest Pharmaceuticals ov...

CDER into Bispecific Antibody Research, Application

[ Price : $8.95]

An FDA online paper describes CDER research into and clinical applications of bispecific antibodies.

Regeneron Responding to Eylea Complete Response

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Regeneron says it will respond to a recent FDA complete response letter on the companys BLA for a higher dose of Eylea (aflibercep...

RenatiLabs Illegally Marketing WJMAX

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FDA warns Erlanger, KY-based RenatiLabs that it is illegally marketing human cell products that are manufactured with significant ...

Device Recognized Standards List Modified

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Federal Register notice: FDA announces the publication of modifications the agency is making to its list of standards recognized f...

Info Collection on New Dietary Ingredients

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Federal Register notice: FDA seeks comments on an information collection revision entitled Premarket Notification for a New Dietar...

FDA Warns Centaur on CGMP Issues

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FDA warns Centaur Pharmaceuticals about CGMP issues in its manufacturing of drugs at its facility in Maharashtra, India.

Advancing RWE Program Deadline Coming

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FDA says the deadline for submissions for the next cycle of the Advancing Real-World Evidence program is 9/30.

PEPFAR Antiretroviral Drug Guidance

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FDA publishes a draft guidance with recommendations for single-entity and fixed-combination antiretroviral drugs to be distributed...

Broader Scientific Topics for Advisory Panels: Bumpus

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FDA chief scientist Namandj Bumpus says the agency is looking to revamp its advisory committees to convene panels that will solici...