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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.

Guidance on Necessity of IND

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Federal Register Notice: FDA releases a guidance: Investigational New Drug Applications (INDs) Determining Whether Human Research...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Bio Focus, Dako Denmark, Deroyal Cientifica De Latinoamerica, Graftys, Irenda, S...

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...