FDA Related News

Medical Devices

Breakthrough Devices Updated Final Guidance

FDA publishes an updated final guidance on the Breakthrough Device program.

Medical Devices

De Novo Granted for Esophagus Cooling Device

FDA grants Attune Medical a de novo marketing authorization for its ensoETM device and its use to reduce the likelihood of ablation-related esophageal...

Federal Register

FDA Seeks Input on Drug Quality Management Maturity

Federal Register notice: FDA establishes a docket to solicit stakeholder comments to assist the agency in developing a Quality Management Maturity pro...

Forms FDA 3988 and 3989 Guidance

FDA publishes a guidance on using forms FDA 3988 and 3989.

Human Drugs

AI is FDA Info Technology Plans Top Goal

FDA says exploring how artificial intelligence can play a role in its regulatory operations is a top strategic goal of its just-released four-year inf...

Medical Devices

FDA 2 Weight Loss Device Guidances

FDA publishes draft guidances to support clinical and non-clinical testing in premarket submissions for medical devices with a weight loss indication.

Human Drugs

FTC Warns on Improper Orange Book Patent Listings

The Federal Trade Commission issues a policy statement, which is supported by FDA, warning brand-name pharmaceutical companies that they could face le...

Human Drugs

FDA OKs Updated Temodar Indications

FDA approves updated and revised labeling for Mercks Temodar under the Oncology Center of Excellence Project Renewal pilot program.

Human Drugs

FDA Clarifies Safety of Phenylephrine Products

FDA issues a safety clarification about its 9/12 Non-prescription Drug Advisory Committees decision that current scientific data do not support the ef...

Human Drugs

Zydus Petition on Indocin Suppositories

Zydus Pharmaceuticals asks FDA to ensure that Indocin suppositories and their generics meet ICH guidelines and established impurity acceptance criteri...