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Preemption Defense Opportunities, Pitfalls

[ Price : $8.95]

Attorney Grant Hollingsworth outlines Trump administration changes that could positively or negatively affect a preemption defense...

FDA Cites Data Integrity, Quality Control at Aurobindo Facility

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FDA cites significant data integrity and quality control failures at an Indian manufacturing facility operated by Aurobindo Pharma...

FDA Accepts Sibel Aria Cough Sensor in DDT

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FDA accepts the Sibel Aria cough sensor into its Drug Development Tool qualification program.

Genentech NDA for Breast Cancer Therapy

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FDA accepts for review a Genentech NDA for giredestrant for treating patients with endocrine-resistant breast cancer.

Court Dismisses Suit Seeking FDA Pathway for Alzheimers

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A Maryland federal judge dismisses a physicians bid to force FDA to create a special, conditional access pathway for certain exper...

FDA Grants Priority Review to Savaras Molbreevi

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FDA accepts for priority review a Savara BLA for Molbreevi as a treatment for autoimmune pulmonary alveolar proteinosis.

CDERs Hoeg has SSRIs, mAbs in Crosshairs

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CDER acting director Tracy Beth Hoeg says the Center is preparing new safety reviews of widely used antidepressants and monoclonal...

Hyloris Pharma NDA Held Up Over Inspection Issues

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Hyloris Pharmaceuticals says a recent FDA inspection of its Greek manufacturing partner resulted in an Official Action Indicated d...

Petition Seeks Restrictions on Robotic Surgical Device

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A patient safety group urges FDA to rescind or narrow a recent device clearance that allows use of a robotic surgical system in ni...

19-page Lupin FDA-483 Out

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FDA releases the 19-page form FDA-483 with seven observations from an inspection at the Lupin drug manufacturing facility in Verna...