FDA Related News

Federal Register

Guide on Peripheral Vascular Atherectomy Devices

Federal Register notice: FDA releases a draft guidance entitled Peripheral Vascular Atherectomy Devices Premarket Notification [510(k)] Submissions....

Federal Register

Metaxalone not Withdrawn Due to Safety/Effectiveness: FDA

Federal Register notice: FDA determines that metaxalone tablets, 640 mg were not withdrawn from sale for reasons of safety or effectiveness.

Medical Devices

Adherium Sensor Cleared for Asthma Inhaler Compliance

FDA clears an Adherium 510(k) for its Hailie sensor and its use with Tevas ProAir HFA, and GlaxoSmithKlines Ventolin HFA and Flovent HFA asthma inhale...

Human Drugs

Rare Disease Effectiveness Guidance

FDA issues a draft guidance to help sponsors understand the evidence necessary to demonstrate effectiveness of drugs used for slowly progressive, low-...

Human Drugs

2 New Drug Quality Metric Programs

CDER director Janet Woodcock and Office of Pharmaceutical Quality director Michael Kopcha describe two new voluntary quality metric programs available...

Medical Devices

FDA Clears Carbon Fiber Pedicle Screw System

FDA clears a CarboFix 510(k) for the CarboClear Carbon Fiber Pedicle Screw System, a device intended to surgically treat oncological patients.

Ex-FDA Investigator Grumet Joins Greenleaf Health

Regulatory consulting firm Greenleaf Health adds former FDA field investigator Kristen Grumet as senior vice president for regulatory compliance.

Human Drugs

FDA Clarifies Field Action Reports Guidance

Attorney Jennifer Davidson outlines clarifications included in a draft FDA guidance on submission of field alert reports.

Human Drugs

Final Orphan Pediatric Drug Designation Guidance

FDA announces availability of a finalized guidance on orphan drug designation for pediatric subpopulations of common diseases.

Medical Devices

Guide on Peripheral Vascular Atherectomy Devices

FDA releases a draft guidance entitled Peripheral Vascular Atherectomy Devices Premarket Notification [510(k)] Submissions.