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WSJ Apologizes for Supporting Califf

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An unusually strident Wall Street Journal editorial apologizes to its readers for supporting FDA commissioner Robert Califfs appoi...

Dupixent COPD sBLA May Face Review Delay

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Regeneron faces a potential approval delay on its supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in ...

Bill to Restrict Revolving Door When FDAers Depart

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A just-introduced bill, Fixing Administrations Unethical Corrupt Influence Act, restricts top federal health officials at FDA, CDC...

Inspections Reviewing More Promo Materials: Law Firm

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FDA increases its surveillance of promotional materials during inspections, according to a client bulletin by Arnall Golden Gregor...

Meeting Set for Schizophrenia Trial Considerations

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FDA announces an 8/16 public meeting on Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials to discuss approaches...

Eugia Pharma Gets Fourth FDA-483 in 2024

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FDA issues Eugia Pharma Specialities its fourth Form FDA-483 of the year after concluding an inspection of the firms formulation m...

Giron Debarred Over Investigator Misconduct

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Federal Register notice: FDA issues an order permanently debarring Angela Maria Giron from providing services in any capacity to a...

Q-Submission Guide Step in the Wrong Direction: Expert

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Hyman, Phelps & McNamara senior medical device regulation expert Lisa Baumhardt critiques a recent FDA draft guidance on the Q-Sub...

Office of Translational Sciences Annual Report

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The CDER Office of Translational Sciences 2023 annual report lists achievements in seven program areas.

Mass Spectrometry Guide for Animal Drugs

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FDA posts a final guidance entitled Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.