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Praxis 510(k) for Biopsy Device Cleared

[ Price : $8.95]

FDA clears a Praxis Medical 510(k) for its EndoCore EBUS-TBNA fine needle biopsy device.

Former FDA Lawyer Joins Faegre Drinker

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After 15 years at FDA, former senior regulatory counsel Joy Sharp joins the law firm Faegre Drinker as counsel in Washington, DC.

Keytruda OKd Before/After Lung Cancer Surgery

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FDA approves Mercks Keytruda (pembrolizumab) for use with platinum-containing chemotherapy as neoadjuvant treatment and continuing...

Testing Pharma Alcohols for Methanol Guide

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Federal Register notice: FDA makes available a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcoh...

Guide on Diabetic Foot Infection Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.

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...