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2 Final Post-Approval Activity Guidances

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FDA publishes two final guidances to facilitate the timely start and finish of medical device post-approval studies and postmarket...

Essure Postmarket Study Inadequate: FDA

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FDA says Bayer is making inadequate progress in a postmarket surveillance study of its Essure birth control device.

Lilly Fast Track for Obesity Drug

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FDA grants Eli Lilly a fast track designation for tirzepatide and its use for treating adults with obesity, or overweight with we...

Medical Device User Fee Rates Set

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Federal Register notice: FDA sets the medical device user fee rates and payment procedures for fiscal year 2023.

Aurora Spine SiLO Sacroiliac Device Cleared

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FDA clears an Aurora Spine 510(k) for its SiLO TFX MIS Sacroiliac Joint Fixation System.

Rx Drug User Fee Rates Set

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Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2023.

Roches Pathway Test OKd for Low HER2

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FDA approves a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast canc...

Revatio sNDA for Pulmonary Hypertension Heads to Panel

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Federal Register notice: FDA announces a 12/14 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Viatris Spec...

Panel to Discuss Heart Failure Drug

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Federal Register notice: FDA announces a 12/13 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Cytokinetics ...

IR, DRL Guidance

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FDA publishes a guidance with updated GDUFA 3 information on information requests and discipline review letters.