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Clinical Investigation Protocol Deviations

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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.

Updated POLARx Instructions is Class 1 Recall: FDA

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FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.

CGMP Violations in Akorn Formulations Review

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FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...

Syndax Leukemia Review Extended by FDA

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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.

FDA OKs Merck Kidney Cancer Drug

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FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death r...

FDA OKs Glaukos Intraocular Pressure Drug Implant

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FDA approves a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reduc...

2 Imbruvica Accelerated Approvals Withdrawn

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Federal Register notice: FDA withdraws approval of the indications for mantle cell lymphoma and marginal zone lymphoma for Pharmac...

DTC Survey Examines Quantitative Claims

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Federal Register notice: FDA sends to OMB an information collection proposal entitled A Survey on Quantitative Claims in Direct-to...

FDA Updates Breast Implant Safety Info

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FDA updates its Risks and Complications of Breast Implants Web page that clarifies information about implant removal and adds ultr...