Human Drugs
Guide on Biosimilar Product Formal Meetings with FDA
FDA makes available a guidance on formal meetings between FDA and sponsors or applicants of biosimilar products.
Human Drugs
Hospira Recalls 2 Lots of Naloxone HCl
Hospira recalls two lots of naloxone hydrochloride injection, 0.4 mg/mL, 1 mL in 2.5 mL in its Carpuject single-use cartridge syringe system due to th...
Medical Devices
Alert on Intragastric Balloon Devices After More Deaths
FDA alerts health care providers about five additional deaths associated with the use of liquid-filled intragastric balloon devices for obesity treatm...
Medical Devices
Micronics 510(k) for PanNAT E. coli Test
FDA clears a Micronics 510(k) for its PanNAT STEC Test and its use in detecting Shiga toxin-producing E. coli.
Medical Devices
Spineology Rampart Interbody Fusion Device Cleared
FDA clears Spineology 510(k) for its Rampart One Standard ALIF interbody fusion system for use with or without supplemental fixation.
Human Drugs
Mylans Neulasta Biosimilar Approved by FDA
FDA approves Mylans Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Amgens Neulasta (pegfilgrastim) to decrease the chance of infection as su...
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 6/1/2018.
Medical Devices
Medicrea 510(k) Cleared for 3D-Printed Spinal Cage
FDA clears a Medicrea Group 510(k) for patient-specific spinal cages through the extension of its UNiD ASI (Adaptive Spine Intelligence) technology to...
Human Drugs
FDA Approves Lilly/Incyte Arthritis Drug
FDA approves an Eli Lilly and Incyte NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active...
