Medical Devices
Fresenius Kabi Recalls Infusion Pumps
Fresenius Kabi recalls its Volumat MC Agilia Infusion Pumps and Vigilant Agilia Drug Library due to alarm and multiple software errors.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/9/2019.
FDA General
Since Our last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 8/9/2019.
Human Drugs
Suit Seeks Info on Any Sharpless Drug Conflict
Watchdog group Restore Public Trust files suit to get FOI documents on whether FDA acting commissioner Ned Sharpless is asserting any influence at the...
Human Drugs
Public Meeting Seeks Priorities for New Drug Review
FDA says it is planning an 11/7 public meeting to seek input on opportunities and priorities for CDERs Office of New Drugs.
Human Drugs
Kala Pharma Dry Eye NDA Rejected; More Data Needed
FDA issues Kala Pharmaceuticals a complete response letter on its NDA for KPI-121 (loteprednol etabonate) for dry eye disease signs and symptoms.
Human Drugs
FDA Tests New BE Method for Generic Topicals
A new FDA Impact Story discusses new research undertaken to help would-be generic topical dermatological drug product developers demonstrate bioequiva...
Human Drugs
Ortho Dermatologics NDA Accepted for Acne Lotion
FDA accepts for review an Ortho Dermatologics NDA for tazarotene 0.045% lotion for treating moderate to severe acne.
Human Drugs
Amarin Expects Review Extension on Vascepa sNDA
Amarin says FDA likely will extend its review of a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules after reveal...
