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Is Chevron Deference Dead?: Ex-FDAer Pitts

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Former FDAer Peter Pitts asks if FDA is going too far in seeking deference in a court case involving Regenative Labs Whartons Jell...

Guilty Plea in SphenoCath Case

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The Justice Department says former Dolor Technologies CEO Mark Wright has pleaded guilty to misdemeanor charges of introducing adu...

FDA Wants Comments on Innovative Clinical Trials

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CDER asks for comments on barriers and facilitators to incorporating innovative clinical trials in drug development programs.

Verrica Asks FDA to End Ycanth Compounding

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Verrica Pharmaceuticals asks FDA to take steps to stop the compounding of its Ycanth molluscum contagiosum treatment.

6 Observations in Samsung Biologics FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at the Samsung Biologics drug manufacturing facility in Inc...

Fast Track for Glioblastoma Vaccine

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FDA grants Diakonos Oncology a fast-track designation for the companys dendritic cell vaccine, DOC1021, for use in patients with g...

Hear Danco Mifeprex SCOTUS Appeal: PhRMA

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PhRMA calls on the Supreme Court to hear a Danco Laboratories/FDA appeal of a 5th Circuit Court of Appeals decision restricting us...

FDA Denies UCB Generic Fintepla Petition

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FDA denies without comment the specific requests in a UCB petition asking the agency to not approve an Apotex ANDA for generic Fin...

Omeros Discontinues Narsoplimab Development

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Omeros stops the development of narsoplimab for treating immunoglobulin A nephropathy based on Phase 3 clinical trial data that di...

Skyrizi Better Than Stelara: AbbVie Data

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AbbVie reports positive results from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of its Skyrizi...