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FDA Commissioner Makary Resigns After Administration Pressure

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FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was prep...

Clarify Draft on FDA-483 Responses: Comments

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Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.

CDER Wants Info for Kidney Safety Biomarker Pilot

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An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project foc...

Ipsen Pulls Tazverik Due to Secondary Blood Cancer Risk

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Ipsen withdraws its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased ris...

FDA Cites SCA Pharmaceuticals Over Sterility, Contamination Control

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A March inspection of SCA Pharmaceuticals cites multiple manufacturing and contamination-control deficiencies at its outsourcing f...

FDA Input Sought on Drug Repurposing

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FDA seeks public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet ...

Guide on Developing Clostridioides Difficile Infection

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FDA issues updated guidance for companies developing therapies to treat, prevent or reduce recurrence of Clostridioides difficile ...

Staska Pharma Hit with FDA Form 483

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An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.

FDA Guide on Developing Drugs for Pulmonary Tuberculosis

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FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, e...

FDA Delays Review Action on Alzheimers Drug

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FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation of Alzheimers drug Leqembi (l...