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Digital Health Advisory Committee Established

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Federal Register notice: FDA amends its standing advisory committee regulations to add the new Digital Health Advisory Committee.

Vet Third-Party Device Data: FDA

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FDA cautions device manufacturers to evaluate the performance data provided by third-party labs for use in agency submissions.

CBER Postmarket Requirement/Commitment SOPP

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CBER publishes a SOPP for the administrative handling, review, and reporting of postmarketing requirements and commitment submissi...

Steps to Address Drug and Device Shortages

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Two Coalition for a Prosperous America policy experts outline steps they say the federal government, including FDA and Congress, c...

REMS Can be Improved: Doc Survey

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An FDA-funded survey of doctors who prescribe REMS-covered drugs finds that many doctors appreciate and use the REMS information a...

X-trodes Wearable Electrophysiological Monitor Cleared

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FDA clears an X-trodes 510(k) for its X-trodes Smart Skin device, a wireless wearable technology for advanced electrophysiological...

Harmony Bio Granted Orphan Status for Pitolisant

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FDA grants Harmony Biosciences Holdings an orphan drug designation for pitolisant and its use in treating Prader-Willi syndrome.

Merck Keytruda sBLA for Endometrial Cancer

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FDA accepte for priority review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treati...

ARS Pharma Responding to Complete Response

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ARS Pharmaceuticals says new study data will be submitted in the second quarter as part of a response to a 9/2023 FDA complete res...

API Manufacturing Deviations at Sichuan Deebio

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FDA warns Chinas Sichuan Deebio Pharmaceutical Co. about significant deviations in manufacturing active pharmaceutical ingredients...