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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Federal Register notice: FDA makes available a draft guidance entitled Inclusion of Older Adults in Cancer Clinical Trials.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FDA posts a draft guidance on Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment.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.

Medical Devices

Bill to Improve Diagnostic Test Regulatory Impediments

U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) introduce the bipartisan Verifying Accurate, Leading-edge IVCT Development Act that is intend...

Human Drugs

Hikma Pharma Expanded Recall of Ketorolac Tromethamine

Hikma Pharmaceuticals extends a previously announced recall of certain lots of ketorolac tromethamine injection USP 30mg/mL, 1mL fill/2mL vials due to...

Biologics

HCT/Ps Regulation Deviations at Reproductive Technologies

FDA warns Reproductive Technologies about significant deviations from regulations for human cells, tissues, and cellular and tissue-based products.