FDA Related News

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Federal Register notice: FDA has made available a draft guidance entitled Content of Premarket Submissions for Management of Cybersecurity in Medical ...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

Federal Register

Class 2 for Upper Limb Tremor Stimulator

Federal Register notice: FDA classifies the external upper limb tremor stimulator into Class 2 (special controls).

Human Drugs

Teva Sues FDA Over Generic Restasis Exclusivity

Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.

FDA General

Walmarts Yiannis Named FDA Deputy Commissioner

FDA commissioner Scott Gottlieb announces the appointment of Walmart executive Frank Yiannis as deputy commissioner for food policy and response.

Medical Devices

Stakeholders Want More Device Accessories Reclassified

Stakeholders ask for changes to an FDA list of medical device accessories proposed for down-classification to Class 1.