FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Medical Devices

Thermo Fisher Gets Fast EUA for Coronavirus Test

FDA issues the fourth coronavirus Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit diagnostic.

Human Drugs

Endologix PMA OKd for Abdominal Stent Graft

FDA approves an Endologix PMA Alto Abdominal Stent Graft System (Alto) for endovascular abdominal aortic aneurysm repair.

Human Drugs

Sen. Warner Wants Drug Making Moved Back to U.S

Sen. Mark Warner (D-VA) writes HHS urging it to develop a long-term plan to move pharmaceutical manufacturing back to the U.S. to reduce reliance on f...

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Human Drugs

Guide on Rare Diseases with Substrate Deposition

FDA posts a final guidance on slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects.

Medical Devices

TransEnterix 510(k) for Intelligent Surgical Unit

FDA clears a TransEnterix 510(k) for the Intelligent Surgical Unit (ISU) that enables machine vision capabilities on the Senhance Surgical System.

Federal Register

Panel to Review TransMedics Organ Care System

Federal Register notice: FDA announces a 4/16 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting that will review the ...

Federal Register

Final Guide on Biological Deviation Reporting

Federal Register notice: FDA makes available a final guidance entitled Biological Product Deviation Reporting for Blood and Plasma Establishments.

Federal Register

Info Collection on Device Inspection Feedback

Federal Register notice: FDA sends to OMB an proposed information collection entitled Requests for Nonbinding Feedback After Certain FDA Inspections o...

Human Drugs

Roche EUA for Cobas Coronavirus Test

FDA issues Roche Molecular Systems an emergency use authorization for its cobas SARS-CoV-2 test for diagnosing coronavirus (COVID-19).