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FDA Posts Device Development Tool on Cybersecurity

[ Price : $8.95]

FDAs Medical Device Development Tools program lists an agency-qualified tool that medical device sponsors can use in developing an...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Medoz Pharmacy of Polk and RLC Labs.

CDRH Web Site on Priority Guidance Development

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Federal Register notice: FDA announces the Web site location where it will post two lists outlining guidance documents that CDRH i...

Nonvoting Industry Reps for Device Panels Sought

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Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representati...

Ossiofiber Compression Screw Portfolio Cleared

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FDA clears an Ossio 510(k) for its Ossiofiber Compression Screw Portfolio for alignment maintenance and fixation of bone fractures...

FDA Gives Full Approval to Venclexta

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FDA grants full approval for AbbVie and Roches Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose ...

Update on FDAs Technology Modernization Plan

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FDA says that under its technology modernization plan it is accelerating the implementation of a software defined network and adop...

CDRH Discussion Paper on Communicating Cybersecurity Issues

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FDA seeks feedback on a discussion paper entitled Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Fr...

GAO to Probe Trump Administration Political Interference

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The Government Accountability Office agrees to conduct an investigation of the Trump Administrations alleged political interferenc...

New eCTD Module Use Requirement

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FDA is announcing a requirement for electronic submissions to be submitted using a new Electronic Common Technical Document Module...