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Arrow Thrombolytic Device Recall Class 1

[ Price : $8.95]

FDA says an Arrow International recall of its Arrow-Trerotola percutaneous thrombolytic device is Class 1.

Boehringer Gets Breakthrough on Pulmonary Fibrosis Drug

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FDA grants Boehringer Ingelheim Pharmaceuticals a breakthrough therapy designation for its investigational therapy BI 1015550 and ...

Apricus Selling Vitaros ED Cream Rights

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Apricus Biosciences says it cant afford to do what FDA says is needed for a Vitaros NDA resubmission and it is shopping the U.S. r...

7 Observations in Denver Solutions FDA-483

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FDA releases an FDA-483 with seven observations from an inspection at Englewood, CO-based Denver Solutions outsourcing facility.

FDA Broadens Jardiance Heart Failure Indication

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FDA approves a new Jardiance indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adults...

Viz.ai Aneurysm Module Cleared by FDA

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FDA clears a Viz.ai 510(k) for the Viz Aneurysm module and its use on the Viz Intelligent Care Coordination Platform for detecting...

United Therapeutics NDA Review Extension for Tyvaso

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FDA extends its review of a United Therapeutics NDA resubmission for Tyvaso DPI (inhaled treprostinil) after receiving an informat...

Proposal to Harmonize Device QSR with ISO 13485

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Federal Register notice: FDA publishes a proposed rule to amend medical device current GMP requirements of the Quality System Regu...

FDA Opens Compounding MOU Study

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FDA says it will open notice-and-comment rulemaking to analyze the impact of a memorandum of understanding between it and states o...

Comments on Physiologic Closed-Loop Guidance

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Three stakeholders comment on an FDA draft guidance on technical considerations for medical devices with physiologic closed-loop c...