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Regeneron Responding to Eylea Complete Response

[ Price : $8.95]

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...

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FDA publishes a draft guidance with recommendations for single-entity and fixed-combination antiretroviral drugs to be distributed...