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Medical Devices

FDA Guide on Requesting Rationales of Significant Decisions

FDA posts a guidance on Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A.

Medical Devices

Guidance on Diagnostic Radiology Display 510(k) Submissions

FDA releases a guidance on Display Devices for Diagnostic Radiology that is intended to assist industry in preparing premarket notification submission...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 9/29/2017.

Medical Devices

Guidance on Deficiencies in Device Submissions

FDA makes available a guidance on Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.

Federal Register

Guide on Oncology Reproductive Toxicity Testing

Federal Register notice: FDA makes available a draft guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommenda...

Federal Register

Comments Sought on Opioid Policy Committee

Federal Register notice: FDA seeks comments or suggestions on issues relevant to the agencys newly established Opioid Policy Steering Committee.

Human Drugs

Aegerion Corporate Integrity Agreement Revealing: Attorneys

A recent corporate integrity agreement between Aegerion Pharmaceuticals and HHS Office of Inspector General provides insights into the safeguards OIG ...

Medical Devices

FDA Clears K2M Yucon Spinal System

FDA clears a K2M Group Holdings 510(k) for its Yukon Oct Spinal System, a device intended to facilitate fusion with posterior fixation in the occipito...

FDA General

HHS Secretary Price Resigns Amid Chartered Aircraft Scandal

HHS secretary Tom Price resigns amid a furor over his use of expensive private chartered aircraft for government travel.

Human Drugs

FDA Rejects Intellipharmaceutics Extended Release Opioid

FDA issues Intellipharmaceutics International a complete response letter on its Rexista (oxycodone hydrochloride) extended-release tablets for treatin...