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2 New MAPPs Out

[ Price : $8.95]

CDER issues Manuals of Policies and Procedures on scientific interest groups and data standards.

MiRus Lumbar Interbody Device Cleared

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FDA clears a MiRus 510(k) for its IO Expandable Lumbar Interbody device for use in posterior and transforaminal fusion procedures.

UCB Gets Expanded Pediatric Indication for Briviact

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FDA approves a UCB expanded indication for Briviact (brivaracetam) tablets, oral solution, and injection to treat partial-onset se...

Anixa Gains IND Approval of CAR-T for Ovarian Cancer

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FDA approves an Anixa Biosciences IND for its CAR-T (Chimeric Antigen Receptor-T cell) therapy and its use in treating ovarian can...

Guide Revised on Trials Conducted During Covid

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FDA revises its guidance entitled Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency.

De Novo Granted for Smart Knee Replacement

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FDA grants a de novo authorization to Zimmer Biomet and Canary Medical for their tibial extension for Persona IQ, the first smart ...

Lantern Pharma Gets Orphan Status LP-184

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FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating glioblastoma multiforme and other malignan...

EUA Withdrawn for Curative Covid Assay

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Federal Register notice: FDA announces that it has revoked the Emergency Use Authorization issued to Curative Inc. for its Curativ...

2 Guides on Device Performance Based Pathway

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Federal Register notice: FDA makes available two draft device-specific guidance documents for the Safety and Performance Based Pat...

Breckenridges Solifenacin Succinate ANDA Withdrawn

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Federal Register notice: FDA withdraws the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg a...