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End-of-December Warning Letters

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FDA releases substantive Warning Letters in the last two weeks of December 2025.

FDA Releases Sun Pharmaceutical FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at the Sun Pharmaceutical Medicare sterile drug manufactu...

Industry Recommendations for BsUFA 4 Reauthorization

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A Hyman, Phelps & McNamara CMC regulatory expert lists the initial industry recommendations for improvements to be negotiated in t...

FDA to Review Inovio BLA to Treat RRP

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FDA accepts for review an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis.

Alumis Positive Data Reported for Psoriasis Drug

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Alumis says envudeucitinib delivered high levels of skin clearance in two pivotal Phase 3 trials in moderate-to-severe plaque psor...

Dexcom Glucose Monitor Software Correction is Class 1

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FDA says a recent Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous glucose monitoring software is Clas...

FDA Town Hall on Quality Management System Regulation

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FDA announces a 1/14 town hall to discuss its Quality Management System Regulation (QMSR) and its effective date of 2/2/2026.

13 Potential New FAERS Drug Safety Signals

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FDA releases a list of 13 potential safety signals identified in drugs between 7/2025 and 9/2025.

First Cycle Review Metrics Debated at PDUFA Session

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In a PDUFA 8 reauthorization subgroup discussion, FDA and industry representatives trade data and evaluations of first-cycle revie...

FDA Seeks Alternate Path to Fed Contracting for Tech Access

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FDA seeks input on a new way to contract directly with venture capitalbacked innovators in an effort to possibly speed adoption of...