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PharmaTher to Work with FDA on Ketamine Phase 3 Study

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PharmaTher says it will work with FDA toward a Phase 3 trial of its ketamine infusion to treat levodopa-induced dyskinesia in Park...

Top Warning Letter Drug GMP Citations

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CDER Office of Manufacturing Quality branch chief Maan Abduldayem outlines the Centers Top Recent Warning Letter Citations (FY 201...

Obstetrics, Reproductive Drugs Panel Renewed

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Federal Register notice: FDA renews its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years...

Artio Medical Embolization Device Cleared

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FDA clears an Artio Medical 510(k) for its Solus Gold Embolization Device for peripheral vascular occlusion.

Complete Response Letter for Takedas Natpara

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FDA issues a complete response letter saying it cannot approve at this time a Takeda prior approval supplement for its Natpara hyp...

Guide on Ophthalmic Drugs Compliance Policy

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Federal Register notice: FDA makes available a final guidance entitled Certain Ophthalmic Products: Policy Regarding Compliance Wi...

Pfizer Recalling Lots of Accuretic, Others

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Pfizer recalls branded and authorized generic lots of Accuretic tablets due to the presence of a nitrosamine above the acceptable ...

ECI Pharmaceuticals Warned About Listing Violations

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FDA warns Fort Lauderdale, FL-based ECI Pharmaceuticals about listing violations for two estrogen products that have been removed ...

Bone, Reproductive and Urologic Drugs Panel Name Change

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Federal Register notice: FDA changes the name and function of the Bone, Reproductive and Urologic Drugs Advisory Committee to Obst...

CDER Input on CMC Changes Experience

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CDER Office of Policy for Pharmaceutical Quality director Ashley Boam details the Centers new experience with the ICH Q12 final gu...