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MDR, QS Violations Found at Deroyal Cientifica

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FDA warns Costa Ricas Deroyal Cientifica de Latinoamerica about MDR and QS violations in its manufacturing of medical devices.

FDA Announces Opioid Safety Labeling Changes

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FDA orders labeling changes and revised REMS for extended-release and long-acting opioids.

Guidance on IND Applications Out

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FDA issues guidance on when an IND is needed in human research studies.

Advisors Back Anoro Ellipta Safety, Effectiveness

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FDA Pulmonary/Allergy Drug Advisory Committee members tell the agency there is sufficient safety and efficacy data to support appr...

FDA Warns Graftys About MDR, QS Violations

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FDA warns Graftys about MDR and QS violations in its manufacturing of bone void fillers.

Genentech sBLA for Perjeta Expanded Use has Supportive Data: FDA

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FDA says a Genentech supplemental BLA contains statistically significant clinical trial results for an expanded use for Perjeta (p...

FDA Outlines Path for Generic Advair Products

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FDA releases a draft guidance that outlines a path for generic companies to market copies of GlaxoSmithKlines Advair (fluticasone ...

Q&A Guidance on Generic Drug User Fees

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Federal Register Notice: FDA releases a draft guidance: Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision ...

Another Pharmacy Compounder Recall Due to Contract Lab

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Another drug compounding pharmacy recalls products due to concerns about the adequacy of testing performed by contract testing lab...

FDA Clears Care Innovations Remote Care Manager

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FDA clears a Care Innovations 510(k) for its Connect RCM (Remote Care Management) client application.