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Characterizing MRD Data in Cancer Trials

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FDAers in CDER and the Oncology Center of Excellence discuss the use of minimal residual disease (MRD) data in hematologic clinica...

Servier Phase 3 Data Supports Glioma Drug Vorasidenib

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Servier says a Phase 3 clinical trial assessing glioma drug vorasidenib met its primary and secondary endpoints.

Petition Against BDs Breast Reconstruction Device

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A former Becton Dickinson medical director petitions FDA to scrutinize the companys 2017 510(k) clearance for the GalaForm 3D due...

FDA Webinar on ICH Bioequivalence Guidance

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FDA announces a 5/2 Webcast entitled Navigating the First ICH Generic Drug Draft Guideline M13A Bioequivalence for Immediate-Rele...

FDA Webview Reaches Out for Your Guidance

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Still evolving under the same leadership, Dickinsons FDA Webview asks subscribers to help guide our further development and improv...

FDA Clears PeekMed Orthopedic Surgery Planner

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FDA clears a PeekMed 510(k) for its Web-based artificial intelligence automated planning solution for use in orthopedic surgery.

Most Drug Shortages are Manufacturing Related: FDA

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FDA says the main causes of drug shortages continue to be manufacturing quality issues and manufacturing production delays.

FDA Clinical Hold on Mersana Tumor Drug

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FDA places a clinical hold on Mersana Therapeutics Phase 1 trial of XMT-2056 after the company suspended it due to a recent patien...

Guide on Gastric pH-Dependent Drug Interactions

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FDA posts a final guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, ...

Panel Set to review Intercept Pharma NASH Drug

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Federal Register notice: FDA announces a 5/19 advisory committee meeting to discuss an Intercept Pharmaceuticals NDA for to nonalc...