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FDA Advisory Panel To Review Watchman Device Again

[ Price : $8.95]

FDAs Circulatory System Devices Panel of the Medical Devices Advisory Committee reviews new data on a Boston Scientific PMA for th...

QS Violations Found at Ambco Electronics

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FDAs Los Angeles District Office warns Ambco Electronics about Quality System violations in its manufacturing of audiometers.

Teleflex Recalls Hudson Breathing Circuits

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FDA says Teleflex Medical is recalling Hudson RCI pediatric anesthesia breathing circuits.

FDA Draft Guide on Reducing OTC Acetaminophen Errors

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FDA posts a draft guidance on Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen that provides recommendatio...

Tobacco Center Seeks Tours Program Participants

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Federal Register Notice: FDAs Center for Tobacco Products Office of Science is seeking participants for its Laboratory Sites Tours...

Guidance on Breast Cancer Neoadjuvant Treatment Trials

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Federal Register Notice: FDA releases a guidance:Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage ...

Critical Path Innovation Meeting Guidance Out

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FDA issues a draft guidance on CDER critical path innovation meetings with stakeholders on a new drug development methodology or t...

FDA Mulling New Form 483 Inspection Observation Listing

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FDA considers overhauling the way it records inspectional observations on Form 483s.

BMS Withdraws NDA for Hep C Combination

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Bristol-Myers Squibb withdraws its NDA for a dual regimen of daclatasvir and asunaprevir for treating hepatitis C genotype 1b pati...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Ambco Electronics, ANDAPharm, Hospira Australia, Infopia, Multimmunity, and Nova...