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Info Collection on Device TAP Pilot

[ Price : $8.95]

Federal Register notice: FDA submits to OMB a proposed information collection entitled Voluntary Total Product Life Cycle (TPLC) A...

Comments Sought on IT and Customer Strategy

[ Price : $8.95]

Federal Register notice: FDA requests comments on its Information Technology Strategy and Customer Experience Strategy.

Tempus AI Device for Atrial Fibrillation

[ Price : $8.95]

FDA clears a Tempus AI 510(k) for its Tempus ECG-AF device that uses artificial intelligence to help identify patients at increase...

Fujifilm New CT System Cleared

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FDA clears a Fujifilm Healthcare Americas 510(k) for its new compact, 128-slice computed tomography (CT) system, the FCT iStream.

Public Citizen Ideas to Improve Advisory Committees

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Public Citizen recommends three steps FDA should take to improve the public perception and understanding of the work of agency adv...

14 Submissions with RWE in FY 2023: FDA

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FDA publishes a table with information on 14 drug submissions in FY 2023 that contained real-world evidence.

Sani-Care Salon Products CGMP Violations

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FDA warns Cartersville, GA-based Sani-Care Salon Products about CGMP violations in its work as a contract manufacturer of finished...

HCTP Violations at Indiana Lions Eye Bank

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FDA warns the Carmel, IN-based Indiana Lions Eye Bank about deviations from the regulations for human cells, tissues, and cellular...

NDRP Modernization Successes Lead to Permanent Initiative

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CDER Office of New Drugs Special Program Staff associate director Yoni Tyberg discusses the New Drug Regulatory Program modernizat...

AdvaMed Concerned with Device Remanufacturing Guide

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Advanced Medical Technology Association says there are inconsistencies and ongoing concerns with FDAs guidance on remanufacturing/...