FDA Related News

Federal Register

Nonprescription Drugs Panel Renewed for 2 Years

Federal Register notice: FDA renews its Nonprescription Drugs Advisory Committee for an additional two years.

Federal Register

Circulatory System Panel Meeting on Endovascular Grafts

Federal Register notice: FDA announces an 11/2-3 Medical Devices Advisory Committee Circulatory System Devices Panel meeting to discuss endovascular g...

Federal Register

Panel to Vote on Integra LifeSciences Breast Reconstruction

Federal Register notice: FDA announces a 10/20 advisory committee meeting to vote on a Integra LifeSciences PMA for the SurgiMend PRS Acellular Bovine...

Human Drugs

Cumberland Recruiting MS Study Participants

Cumberland Pharmaceuticals recruits patients for a Duchenne muscular dystrophy cardiomyopathy trial of ifetroban funded by FDA.

FDA General

Draft Guide on PD-1, PD-L1 Alternative Dosing

Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Pr...

Human Drugs

FDA Approves Expanded Age for Ironwoods Linzess

FDA approves a revised label for Ironwoods Linzess expanding the potential for off-label use in children under age 18.

Medical Devices

Court Tosses Boston Scientific Whistleblower Case

Three Sidley Austin attorneys describe a Minnesota federal court decision rejecting a whistleblowers claims that Boston Scientific fraudulently induce...

FDA OKs Expanded Tibsovo Indication Plus Diagnostic Test

FDA approves an expanded indication for Serviers Tibsovo plus a companion diagnostic test to identify patients for the new indication.

Human Drugs

Takeda Illegally Extended Actos Patents: Court

The 2nd Circuit Appeals Court says antitrust suits alleging that Takeda illegally delayed generic entry of its diabetes drug Actos can continue.

Medical Devices

Fuse Medical 510(k) for Knee System

FDA clears a Fuse Medical 510(k) for its Tibial Revision Knee System and the PS Plus Posterior Stabilized Tibial Insert.