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Final Rule Amends Intended Use Regs

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Federal Register final rule: FDA issues a final rule to amend its medical product intended use regulations.

FDA Defends Accelerated Approval Program

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FDA defends the accelerated approval process in the wake of Biogens controversial Alzheimers approval and a new BMJ report that si...

Breakthrough for Biofourmis Heart Software

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FDA grants Biofourmis a breakthrough device designation for BiovitalsHF, a software medical application that is intended to augmen...

RealView Imaging Holographic Device Cleared

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FDA clears a RealView Imaging 510(k) for its Holoscope-i holographic system for creating spatially accurate, three-dimensional int...

Device User Fee Rates for FY 2022

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Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022.

Antimicrobial Panel to Discuss Takeda NDA

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Federal Register notice: FDA announces a 10/7 Antimicrobial Drugs Advisory Committee meeting to discuss Takeda's maribivir.

Biologic Samples/Protocols Requests Extension

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Federal Register notice: FDA sends to OMB an information collection extension entitled Request for Samples and Protocols.

Regen-Cov EUA Expanded to Preventing Covid

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FDA revises Regenerons emergency use authorization for Regen-Cov (casirivimab and imdevimab), expanding its emergency use as post-...

FDA Dismisses JAMA Report on Misclassified Death Reports

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FDA dismisses concerns raised in a JAMA Internal Medicine report that many medical device adverse event reports involving a patien...

TransMedics OCS Lung Solution Cleared for Cold Temp

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FDA clears a TransMedics Group 510(k) for its OCS Lung Solution for use in transplants using cold storage techniques.