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FDA Seeks Quality Process Change in Toripalimab BLA

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FDA issues a complete response letter to Shanghai Junshi Biosciences and Coherus BioSciences on their BLA for toripalimab in combi...

IND Safety Reports eSubmission Guide

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FDA posts a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide.

CDRH Unveils Organizational Changes, New Offices

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CDRH announces organizational changes that include new offices established within the Office of Product Evaluation and Quality.

FDA Hold on Vertex Cell Therapy for Diabetes

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FDA places a clinical hold on a Vertex Pharmaceuticals Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, f...

Bakul Patel Leaving CDRH After 13 Years

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After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel announces he will be leaving the agenc...

FDA Rejects HutchMed NDA Over China Trial Data

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FDA sends HutchMed a complete response letter on its NDA for surufatinib, indicated for treating pancreatic and extra-pancreatic n...

No FDA Action Against Accused Researchers

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FDA denies a Public Citizen petition calling for the disqualification of two researchers at Hennepin County Medical Center, Minnea...

Regeneron Awarded Priority Review Voucher

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Federal Register notice: FDA issues Regeneron Pharmaceuticals a priority review voucher under its material threat medical counterm...

FDA Clears Auris Health Robotic Surgery Device

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FDA clears an Auris Health (Ethicon subsidiary) 510(k) for its Monarch surgery platforms expansion to endourological procedures.

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 4/29/2022.