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DSCSA Waiver, Exception, Exemption Guidance

[ Price : $8.95]

FDA publishes a guidance explaining the process for requesting a waiver, exception, or exemption from provisions of the Drug Suppl...

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

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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...

FDA Floats Food-Animal Antibiotic Use Group

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FDA solicits comments on a report outlining a structure for a public/private partnership to establish and operate a repository of ...

FDA OKs Merck Ebola Vaccine for Children

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FDA approves an expanded indication for Mercks Ebola vaccine Ervebo (Ebola Zaire vaccine, live) to include its use in individuals ...

Imeka Brain White Matter Imaging Cleared

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FDA clears an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to ge...

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...