Federal Register
Comments Sought on Biosimilar Info Collection
Federal Register notice: FDA seeks comments on a information collection extension for General Licensing Provisions; Section 351(k) Biosimilar Applicat...
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 7/6/2018.
FDA General
Latest Federal Register Notices
FDA Review posts the latest Federal Register notices.
Federal Register
Draft Guide on Oncology Therapeutic Radiopharmaceuticals
Federal Register notice: FDA makes available a draft guidance entitled Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Rec...
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...
Human Drugs
Safety Alert on Monsels Solution
FDA advises health care professionals not to use BioDiagnostics Internationals Monsels Solution (ferric subsulfate 20%) because the drug product was m...
