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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.

Final Guide on Revised Covid Test Policy

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Federal Register notice: FDA makes available a final guidance entitled Policy for Coronavirus Disease 2019 Tests During the Publi...

OTC Monograph eSubmission Guide

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Federal Register notice: FDA makes available a draft guidance entitled Providing Over-the-Counter Monograph Submissions in Electro...

FDA Safety Notices Can Affect Liability: Analysis

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Two Hyman, Phelps & McNamara attorneys caution that actions providers take in response to an FDA safety communication could be see...

Feds Interested in FDA-based False Claims Cases: Attorneys

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Covington attorneys say the Justice Department has signaled it remains interested in pursuing False Claims Act cases premised on v...

OTC Monograph Submission Format Guidance

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FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.

FDA Changing Covid Test Review Policy

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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

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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.