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Nature Examines Potential Accelerated Approval Reforms

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The journal Nature examines the problems with FDAs accelerated approval program and potential reforms to reduce any gaming by the ...

HIV Tests Down Classified to 510(k)

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Federal Register notice: FDA issues a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic ...

BridgeBio Pharma Sells Review Voucher for $110 Million

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BridgeBio Pharma sells for $110 million its priority review voucher that was awarded last year when FDA approved Nulibry (fosdenop...

Inspection Findings Sideline UCB Psoriasis Drug

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FDA sends UCB a complete response letter on its BLA for psoriasis-treating bimekizumab, citing deficiencies from a recent preappro...

Scathing FDA-483 Hits Sun Pharma Over GMPs

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A just-released, scathing (XXX INSERT XXX)23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries Halol ma...

Lilly Once-weekly Diabetes Injection Approved

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FDA approves an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Ty...

New BD COR Molecular Diagnostic Platform Cleared

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FDA clears a BD (Becton, Dickinson) 510(k) for its new automated, high-throughput infectious disease molecular diagnostics platfor...

Medtronic Onyx Frontier Drug-eluting Stent OKd

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FDA approves a Medtronic PMA for the Onyx Frontier drug-eluting stent, indicated for treating patients with coronary artery diseas...

FDA Role in Medical Isotope Development

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CDER medical office Joseph Rajendran explains FDAs role in developing technology to produce medical isotopes without using highly ...

FDA Enterprise Modernization Action Plan

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FDA provides an overview of its new Enterprise Modernization Action Plan effort.