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Federal Register

Nonvoting Industry Reps for Device Panels Sought

Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on cert...

Medical Devices

Ossiofiber Compression Screw Portfolio Cleared

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

Human Drugs

FDA Gives Full Approval to Venclexta

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

FDA General

Update on FDAs Technology Modernization Plan

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

Medical Devices

CDRH Discussion Paper on Communicating Cybersecurity Issues

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

FDA General

GAO to Probe Trump Administration Political Interference

The Government Accountability Office agrees to conduct an investigation of the Trump Administrations alleged political interference at FDA and the CDC...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/16/2020.

Federal Register

Patent Listing in Orange Book Comments Extended

Federal Register notice: FDA reopens the comment period for a 6/1 notice entitled Listing of Patent Information in the Orange Book; Establishment of a...

Federal Register

Comments Sought on Covid-19 Guidances

Federal Register notice: FDA makes available three guidance documents related to the Covid19 public health emergency that are subject to comments.

Federal Register

Device Biotin Interference Testing Guidance

FDA posts a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.