FDA Related News

Federal Register

Guide on Bone Anchor 510(k)s

Federal Register notice: FDA makes available a final guidance entitled Bone Anchors Premarket Notification (510(k)) Submissions.

Human Drugs

Market America Multiple Supplement Violations

FDA warns Market America about violations in its distribution of contract-manufactured dietary supplements.

Medical Devices

Guide on Contact Lens Performance Criteria

FDA posts a draft guidance on Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety and Performance Based Pathway.

Clarifications Sought in Transdermal, Topical Draft Guidance

Two companies ask FDA to clarify technical aspects of a draft guidance on the development of transdermal and topical delivery systems.

Medical Devices

QS Violations Found in Silfradent Inspection

FDA warns Italys Silfradent about QS and MDR violations in its manufacturing of the Surgybone medical device.

Human Drugs

KemPharm NDA for ADHD Prodrug

KemPharm files a 505(b)(2) for serdexmethylphenidate, indicated for treating attention deficit hyperactivity disorder.

Medical Devices

FDA/CDC Make More Respirators Available

FDA and the Centers for Disease Control and Prevention take action to make more respirators available to health care personnel because of the coronavi...

Medical Devices

FDA Sees SweynTooth Cybersecurity Vulnerabilities

FDA warns about the SweynTooth family of cybersecurity vulnerabilities.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Acino Products, Chemland, Jiangsu JDC Medical Devices and Silfradent.

Medical Devices

CPAPNEA Medical Supply Optipillows Violations

FDA warns CPAPNEA about multiple violations in its manufacturing of Optipillows.