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FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.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

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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.

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...

Generic Drug Safety Labeling Legislation

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Rep. A Donald McEachin introduces legislation to allow generic drug manufacturers to independently add safety-related information ...

Pediatric Extrapolation is Expanding: Study

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FDA researchers say the use of pediatric extrapolation since 2015 has expanded and been refined.

Clean User Fee Bill Added to Continuing Resolution

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House and Senate negotiators agree to terms to reauthorize the agencys user fee programs under a clean absent any policy/program ...