Human Drugs
Pallone Wants REMS Abuse Hearing
New Jersey Democrat Frank Pallone says the House Energy and Commerce Committee should hold a hearing on drug company efforts to use the FDA REMS proce...
Human Drugs
Oculocare Medical App Cleared for Macular Degeneration
FDA clears an Oculocare Medical 510(k) for Alleye, a mobile medical software application indicated for detecting and monitoring age-related macular de...
Human Drugs
CGMP Violations at Foshan Jinxiong Technology
FDA warns Chinas Foshan Jinxiong Technology about CGMP violations in production of finished pharmaceuticals.
FDA General
Latest Federal Register Notices
FDA Review posts the latest Federal Register notices.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 7/6/2018.
Federal Register
Guide on Biosimilar User Fee Program
Federal Register notice: FDA makes available a final guidance entitled Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.
Human Drugs
FDA Approves Pulmonx Zephyr Endobronchial Valve
FDA approves a Pulmonx PMA for the Zephyr Endobronchial Valve, intended to treat breathing difficulty associated with severe emphysema.
Medical Devices
Arthosurface Arthroplasty System Cleared
FDA clears an Arthrosurface 510(k) to market the Patellofemoral WaveKahuna Arthroplasty System.
Human Drugs
Site Visit Program for Quality Metrics
Federal Register notice: FDA announces a 2018 CDER and CBER staff experiential learning site visit program specific to its Quality Metrics Program.
Human Drugs
Increased Focus on Drug Compounding Facilities
FDA says it is stepping up pressure on drug compounding facilities, particularly those preparing topical pain creams comprised of multiple ingredients...
