FDA Related News

Biologics

Sanofi BLA Filed for Myeloma

FDA accepts for review a Sanofi BLA for isatuximab for treating patients with relapsed/refractory multiple myeloma.

Medical Devices

Centerline Bio OK'd for Surgical Positioning Device

FDA clears a Centerline Biomedical 510(k) for the Intra-Operative Positioning System.

Marketing

Leverage Facebook Health Support Groups: CMI/Compas

CMI/Compas explains how drug companies can use Facebook healthcare support groups.

Grassley, Durbin Want Ad Drug Prices

Sens. Grassley and Durbin say they will push their legislation to require drug companies to publish drug prices in direct-to-consumer TV ads.

Human Drugs

Medicare Part D Opioid Use Down: OIG

The HHS Inspector General says opioid use in Medicare Part D is decreasing and use of medication-assisted treatment is increasing.

Human Drugs

Apokyn ANDAs Should Cover Drug and Device Parts: Petition

U.S. WorldMeds asks FDA not to approve any ANDA for a generic version of its Apokyn that covers only the drug portion of the drug-device combination.

Medical Devices

Biotronik Injectable Cardiac Monitor Cleared

FDA clears a Biotronik 510(k) for the Biomonitor III injectable cardiac monitor.

2 DoJ Whistleblower Policies Explained

K&L Gates attorneys look at the current status and impact of two Justice Department guidances involving False Claims Act whistleblower cases.

Human Drugs

FDA Releases Dr. Reddys FDA-483

FDA releases the FDA-483 with two observations from an inspection at the Dr. Reddys Andhra Pradesh drug manufacturing facility.

Medical Devices

Quality System Violations in Clinicon Inspection

FDA warns Clinicon about Quality System violations in its manufacturing of SureProbe laser accessory probes.