FDA Review posts the Federal Register notices for the week ending 7/21/2017.
Former FDA assistant commissioner for compliance policy and recent HHS deputy general counsel David Horowitz joins Hogan Lovells as a partner.
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.