FDA Review posts the Federal Register notices for the week ending 7/21/2017.
FDA grants Merck tentative approval for Lusduna Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled d...
Federal Register notice: FDA announces three public meetings entitled Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act.
Penumbra begins a Class 1 recall of its 3D Revascularization device because there is a risk that the delivery wire could break or separate during use.
Oscor Inc. recalls certain lots of its ATAR Extension Cable due to a risk of them separating from the connectors during use.
FDA accepts an Amgen BLA for Aimovig (erenumab) for preventing migraine in patients experiencing four or more migraine days per month.
Fujifilm recalls all ED-530XT duodenoscopes after FDA cleared an updated design and labeling request for the device.
Federal Register notice: FDA seeks comments on an information collection extension on its Index of Legally Marketed Unapproved New Animal Drugs for Mi...