FDA Related News

Human Drugs

FDA Requires Singulair Boxed Warning

FDA orders a Boxed Warning to be added to labeling for Mercks Singulair and its generic forms on the risk of neuropsychiatric events.

Government Coronavirus Response: A Series of Missteps

FDA Webview examines a series of avoidable missteps by federal agencies and the Trump Administration in responding to the current coronavirus outbreak...

Medical Devices

Biogennix Gains Expanded Indication for Agilon

FDA clears a Biogennix 510(k) for an expanded indication for its Agilon moldable bone grafting product use in posterolateral spine procedures when mi...

Federal Register

Meeting on Cosmetics International Regulation

Federal Register notice: FDA announces a 4/14 public meeting entitled International Cooperation on Cosmetics Regulation (ICCR) Preparation for ICCR14...

Federal Register

43 Product-Specific ANDA Guidances Posted

Federal Register notice: FDA makes available 43 product-specific guidances for generic drug developers.

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FDA posts a draft guidance on Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety and Performance Based Pathway.

Clarifications Sought in Transdermal, Topical Draft Guidance

Two companies ask FDA to clarify technical aspects of a draft guidance on the development of transdermal and topical delivery systems.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