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CGMP Problems at Chinese Drug Manufacturer

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FDA warns Zhejang Casing of CGMP problems at its drug facility in China.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Angiodynamics, Confidence, Nanjing Maohai Biotech, Velocity Pharma, and Zhejiang...

FDA Approves Perrigos Generic Extina

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FDA approves a Perrigo ANDA for ketoconazole foam, 2%, a generic version of Stiefel Labs Extina Foam.

FDA Issues Tablet Scoring Guidance

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FDA issues a guidance on evaluating and labeling scored drug tablets.

FDA 'Mini Sentinel' Pilot Up and Running

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FDA says a pilot program testing its Sentinel product surveillance system is up and running.

FDA, Talon Agree on Special Protocol for Marqibo

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FDA and Talon Therapeutics reach agreement regarding a special protocol assessment for a planned Phase 3 study of Marqibo (vincris...

Agency Guidance on Sponsor Monitoring of Clinical Trials

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FDA urges medical product sponsors to use centralized methods for monitoring clinical studies conducted on their behalf.

FDA Clears Toshiba Imaging System

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FDA clears a Toshiba America Medical Systems 510(k) for the HDR-08A Imaging System with Kalare R&F technology.

Guidance on Risk-based Monitoring of Clinical Trials

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Federal Register Notice: FDA releases a draft guidance, Oversight of Clinical Investigations: A Risk-based Approach to Monitoring.

Group Petitions FDA on Generic Makers Need to Update Warnings

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Public Citizen petitions FDA seeking to require generic drug makers to update product labeling to warn patients about risks associ...