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No Higher Death Risk in Paclitaxel-Coated Devices: FDA

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FDA says it no longer sees the potential for excess mortality in paclitaxel-coated devices used to treat peripheral arterial disea...

Metabolism Inborn Errors Guidance

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FDA publishes a draft guidance recommending how to optimize and standardize dietary management in clinical trials of drugs to trea...

Info Collection on EUAs for Medical Products

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Federal Register notice: FDA sends to OMB an information collection extension entitled Emergency Use Authorization of Medical Prod...

More Study of Patient-Reported Frailty Needed: FDA

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CDER researchers say a five-item questionnaire they developed successfully used patient-reported data to evaluate frailty in multi...

SCOTUS Should Hear Label Highlights Appeal: PhRMA

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PhRMA asks the Supreme Court to reverse an 11th Circuit Appeals Court decision that held Shire could unilaterally change the Highl...

FDA Enforcement Discretion Policy for Pandemic Tests

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FDA develops a policy for the use of enforcement discretion for unauthorized tests in public health emergencies.

FDA Stalls Xspray Pharmas Dasynoc

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FDA issues a complete response letter for the Xspray Pharma Dasynoc NDA, asking for additional dosing information and information ...

Takeda Withdraws BLA for Dengue Vaccine

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Takeda withdraws a BLA submission for its dengue vaccine candidate, TAK-003, after an FDA discussion on aspects of data collection...

FDA Clears Avatar VR Surgical Planner

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FDA clears the Avatar Medical virtual reality surgical planning solution.