FDA Related News

Federal Register

Regulatory Review Period for Regenerons Dupixent

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals Dupixent.

Federal Register

6 Medical Device Classification Orders Posted

Federal Register notices: FDA makes available six medical device classification orders.

Medical Devices

Abbott HeartMate 3 OKd for Advanced Heart Failure

FDA approves Abbotts HeartMate 3 Left Ventricular Assist Device as a destination therapy for people living with advanced heart failure.

Medical Devices

Warning Letter to Ocular Therapeutix Over Post-Approval Study

FDA issues Ocular Therapeutix a 10/17 Warning Letter over the companys compliance with data collection and information reporting obligations in a post...

Federal Register

Regulatory Review Period for Genentechs Ocrevus

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Genentechs Ocrevus (ocrelizumab).

Experts Divided Over Drug Price Ad Proposal

A Bloomberg Law online post explores differing views on the legality and effectiveness of an HHS proposal to require drug companies to include pricing...

Federal Register

Draft Guide on Cybersecurity for Medical Devices

Federal Register notice: FDA has made available a draft guidance entitled Content of Premarket Submissions for Management of Cybersecurity in Medical ...

Medical Devices

Quik Program Explained in Webinar

A CDRH Webinar reviews the 510(k) Quik pilot program requirements and operation.

Federal Register

Study of Accelerated Approval Disclosures

Federal Register notice: FDA seeks comments on a new proposed research study entitled Experimental Study of an Accelerated Approval Disclosure.

Federal Register

Study on Disease Awareness/DTC Ad Impacts

Federal Register notice: FDA seeks public comments on a proposed research study entitled, Disease Awareness and Prescription Drug Promotion on Televis...