Medical Devices
Asuragen De Novo Granted for Fragile X Test
FDA grants de novo marketing authorization to Asuragens AmplideX Fragile X Dx and Carrier Screen Kit for detecting Fragile X Syndrome.
Human Drugs
GSK sNDA for Zejula as Ovarian Cancer Maintenance
FDA accepts for review a GlaxoSmithKline supplemental NDA for Zejula (niraparib) as a first-line maintenance treatment for women with advanced ovarian...
Medical Devices
Avanos Medical New RF Pain Device Cleared
FDA clears an Avanos Medical 510(k) for its new, 80-Watt Coolief Radiofrequency system for pain-reducing neurological lesion procedures.
Human Drugs
Teva sNDA Approved for ArmonAir Digihaler
FDA approves a Teva Respiratory supplemental NDA for ArmonAir Digihaler (fluticasone propionate) Inhalation Powder, an inhaled corticosteroid for asth...
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/21/2020.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 2/21/2020.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Info Collection for Device Corrections/Removals
Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Reports of Corrections and Removals 21 CFR Pa...
Federal Register
Final Rule Defines Biological Product
Federal Register final rule: FDA issues a final rule to amend its regulation that defines biological product to incorporate changes made by legislatio...
Federal Register
FDA Reclassifying Certain HIV Tests
Federal Register proposed order. FDA proposed to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests a...
