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Final Rule on PMA/HDE Device Announcements

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Federal Register notice: FDA issues a final rule to amend the medical device regulations on procedures for announcing approvals an...

Abbott Cardiac Arrhythmia Mapping Platform Cleared

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FDA clears an Abbott 510(k) for the EnSite EP System with EnSite Omnipolar Technology, a new cardiac mapping platform designed to ...

7 Observations in Med Shop Total Care FDA-483

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FDA releases an FDA-483 with seven observations from an inspection at Longview, TX-based Med Shop Total Care.

Corrected Regulatory Review Period for Enhertu

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Federal Register notice: FDA corrects a notice in the 11/1/2021 Federal Register that announced the regulatory review period for D...

FDA Warns Against LuSys Covid Tests

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FDA warns against using unapproved LuSys Laboratories Covid-19 tests due to a potentially high risk of false results.

Drug Interaction Workshop Summary Out

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FDA and the Duke-Margolis Center for Health Policy publish a summary of a 2019 workshop they co-sponsored on improving the communi...

Draft Guide on Device Discontinuance/Interruption

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Federal Register notice: FDA posts a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufa...

Ways to Fix Accelerated Approval: Professors

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Two professors of medicine and law suggest ways FDA can encourage companies to complete confirmatory trials of drugs reaching mark...

CGMP Violations at Chinas Hubei Kangzheng

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FDA warns Chinas Hubei Kangzheng Pharmaceutical Company about CGMP violations and manufacturing unapproved new drugs.

Tailstorm Health Inspection Observations

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FDA releases the FDA-483 with four observations from an inspection at Chandler, AZ-based Tailstorm Health, an outsourcing facility...