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Federal Register

Public Meeting on FDA/Health Canada ICH Activities

FDA announces a 4/3 public meeting entitled U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Counc...

Human Drugs

FDA OKs Ofev for Lung Disease Scarring

FDA approves Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interstitial lung diseases ...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 3/6/2020.

Federal Register

Draft Guide on Including Older Patients in Trials

Federal Register notice: FDA makes available a draft guidance entitled Inclusion of Older Adults in Cancer Clinical Trials.

Federal Register

Policy for Coronavirus Testing Labs

Federal Register notice: FDA makes available a final guidance entitled Policy for Diagnostics Testing in Laboratories Certified to Perform High Comple...

Federal Register

CDER Regulatory Project Management Site Tours

Federal Register notice: CDER announces its decision to continue Regulatory Project Management Site Tours and Regulatory Interaction Program.

Medical Devices

Class 1 Recall of 774,000 Alaris Infusion Pumps

FDA classifies as Class 1 a Becton Dickinson/CareFusion recall of 774,000 Alaris System infusion pumps and modules due to software and system errors.

Medical Devices

Justice Dept. Sues SpineFrontier Over Kickbacks

The Justice Department files two False Claims Act lawsuits against SpineFrontier and related entities and executives, alleging that the company paid k...

Human Drugs

Draft Guide on Topical Drug Contact Dermatitis

FDA posts a draft guidance on Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment.

Federal Register

Electrical Stimulation Device Ban

Federal Register notice: FDA finalizes a ban on electrical stimulation devices for self-injurious or aggressive behavior.