FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 7/21/2017.
Human Drugs
Merck Gains Tentative OK for Follow-on Basal Insulin
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
3 Public Meetings on Drug Distribution
Federal Register notice: FDA announces three public meetings entitled Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act.
Medical Devices
Penumbra Recalls 3D Revascularization Device
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.
Human Drugs
Oscor Recalls ATAR Extension Cables
Oscor Inc. recalls certain lots of its ATAR Extension Cable due to a risk of them separating from the connectors during use.
Biologics
FDA Accepts Amgen BLA for Migraine Biologic
FDA accepts an Amgen BLA for Aimovig (erenumab) for preventing migraine in patients experiencing four or more migraine days per month.
Medical Devices
Fujifilm Recalls Duodenoscopes to Correct Safety Issues
Fujifilm recalls all ED-530XT duodenoscopes after FDA cleared an updated design and labeling request for the device.
Federal Register
Comments on Unapproved Animal Drugs for Minor Species Listing
Federal Register notice: FDA seeks comments on an information collection extension on its Index of Legally Marketed Unapproved New Animal Drugs for Mi...
FDA General
Former FDAer Horowitz Joins Hogan Lovells
Former FDA assistant commissioner for compliance policy and recent HHS deputy general counsel David Horowitz joins Hogan Lovells as a partner.
