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FDA Radiology CADe Device Guidance

[ Price : $8.95]

FDA publishes a guidance on 510(k) submissions for computer-assisted detection devices applied to radiology images and device data...

Clinical Assessments for Computer Detection Devices Guide

[ Price : $8.95]

FDA issues a revised final guidance entitled Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devic...

Delta Pharma FDA-483 Released

[ Price : $8.95]

FDA releases the form FDA-483 with five observations from an inspection at the Ripley, MS-based Delta Pharma outsourcing facility.

OTC Monograph Submission Format Guidance

[ Price : $8.95]

FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.

FDA Changing Covid Test Review Policy

[ Price : $8.95]

FDA updates its Covid-19 test policy to send more tests through the traditional review pathways and away from emergency use author...

ORA, Field Office Organization Structure Modified

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Federal Register notice: FDA modifies the organizational structure of the Office of Regulatory Affairs and field offices.

Clinical Decision Software Guidance

[ Price : $8.95]

FDA publishes a guidance explaining the scope of its oversight of clinical decision support software in light of changes mandated ...

CGMP Deviations at Zhejiang Tianyu Pharmaceutical

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FDA warns Chinas Zhejiang Tianyu Pharmaceutical Co. about CGMP deviations in the production of active pharmaceutical ingredients.

Tissues Office Renamed Office of Therapeutic Products

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Federal Register notice: CBERs Office of Tissues and Advanced Therapies has modified its organizational structures to redesignate ...

Value in Leveraging Clinical Pharmacology Principles

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CDER Office of Clinical Pharmacology researchers outline the value of leveraging clinical pharmacology principles during drug deve...