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GAO Regenerative Medicine Policy Options

[ Price : $8.95]

A Government Accountability Office report on the challenges of regenerative medicine therapies and technologies offers 11 policy o...

Elevar Therapeutics NDA for Liver Cancer

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FDA accepts for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizu...

CGMP Deviations at Centaur Pharmaceuticals

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FDA warns Mumbai, India-based Centaur Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredie...

Outset Medical Illegally Marketing Tablo System: FDA

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FDA warns San Jose, CA-based Outset Medical it is illegally marketing two medical devices associated with hemodialysis.

Catalent Indiana Facility Cited in Form-483

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FDA gives Catalent a four-page Form FDA-483 after inspecting the firms Bloomington, IN manufacturing facility 5/4-12.

Quidel Cardio Recalls Cardiac Panel Test

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Quidel Cardiovascular recalls the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected tropon...

Guide Updated on Device Development Tools

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FDA updates its final guidance entitled Qualification of Medical Device Development Tools (MDDTs).

Ex-FDA Chief Counsel Joins Berkley Research

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Former FDA chief counsel Dan Troy joins Berkeley Research Group in the firms Washington, DC office as a managing director in its ...

AstraZeneca RSV Drug Beyfortus Approved

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FDA approves an AstraZeneca BLA for Beyfortus (nirsevimab-alip) for preventing Respiratory Syncytial Virus lower respiratory tract...

FDA Announces Priority Review Voucher Issuance

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Federal Register notice: FDA announces the issuance of a priority review voucher to Sarepta Therapeutics for its recently approved...