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Guide on Product-specific Bioequivalence

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Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam....

Panel Shoots Down FibroGens Roxadustat

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FDAs Cardiovascular and Renal Drugs Advisory Committee votes against recommending approval for a FibroGen NDA for roxadustat, indi...

Jubilant Roorkee Facility Under Import Alert

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FDA follows a Warning Letter to Jubilant Pharmovas Roorkee facility with an import alert.

Advisors Support TransMedics OCS Liver System

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Members of the FDA Gastroenterology and Urology Devices Panel vote to support TransMedics OCS liver system with a likely indicatio...

Proposed Study of Medical Conference Drug Promotions

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Federal Register notice: FDA sends to OMB a proposed information collection entitled Medical Conference Attendees Observations Abo...

Using Real-World Evidence in Drug Advertising

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Arnold & Porter attorneys give practical tips for attempting to include real-world evidence in advertising for medicinal products.

DSCSA Enhanced System Draft Guidance Explained

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Winston & Strawn attorneys outline an FDA draft guidance on the enhanced Drug Supply Chain Security Act system for tracking and tr...

Emergent Details New Quality Enhancement Plan

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Emergent Biosolutions responds to an FDA-483 about issues at its Bayview facility that manufactured Covid-19 vaccines and was the ...

iStar Medical Glaucoma Implant Trial OKd

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FDA grants iStar Medical an IDE to begin a pivotal trial with its Miniject implant in over 350 patients with primary open angle gl...

FDA Clears Palliare Insufflation Expanded Use

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FDA clears a Palliare 510(k) for the END-200 tubeset that expands the use of its EVA15 continuous pressure insufflation technology...