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Guidance on Sunscreen Advisory Committee Process

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Federal Register Notice: FDA releases a draft guidance: Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.

FDA Clears Entellus 510(k) for Pediatric Sinus Device

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FDA clears an Entellus Medical 510(k) for its XprESS Multi-Sinus Dilation System for treating maxillary sinuses in patients aged t...

Safety Alert on Intravascular Medical Device Coatings

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An FDA alert warns about intravascular medical devices made by various manufacturers that have the potential for their hydrophilic...

FDA Approves Boehringers Pradaxa for Hip Surgery

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FDA approves a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Pradaxa (dabigatran etexilate mesylate) for preventing de...

Panel to Discuss PMA for Spinal Stabilization System

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Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will meet 2/19 to discuss a PMA for the DIAM Spinal Stab...

FDA Approves BioThrax to Prevent Anthrax Post-exposure

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FDA approves an Emergent BioDefense Operations Lansing BLA for a new indication for BioThrax (Anthrax Vaccine Adsorbed) preventin...

Major Review Concerns on Kyndrisas Safety/Efficacy

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FDA reviewers express major safety/efficacy concerns that may hamper approval of a Biomarin NDA for Kyndrisa (drisapersen) for tre...

FDA Extends Clozapine REMS Certification Deadlines

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Due to ongoing implementation challenges with a new Clozapine Risk Evaluation and Mitigation Strategies program, FDA extends its 1...

Califf Writes on Importance of Patient Perspectives

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A JAMA Viewpoint article authored by FDA commissioner-nominee Robert Califf describes ongoing efforts at the agency on patient pre...

Janssen Files NDA for Invokana/Metformin Combination

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Janssen Research and Development files an NDA for Invokamet XR, a once-daily therapy combining fixed doses of its Invokana canagli...