Mintz Levin attorneys say FDA and industry will need to quickly adapt to OTC monograph reform provisions included in the CARES Act.
The Alliance for Natural Health USA asks FDA to require manufacturers of proton pump inhibitors to include a Warning statement about an increased risk...
FDA issues a CDER MAPP on converting approved ANDAs to temporary approval after receiving a court decision on patent infringement.
FDA grants CNS Pharmaceuticals an orphan drug designation for its lead product berubicin for treating malignant gliomas.
FDA approves Bristol-Myers Squibbs Opdivo for esophageal squamous cell cancer.
FDA warns the owner of OutoftheBoxRemedies.com that it and other Web sites are selling unapproved and misbranded iodine products to treat Covid-19.
FDA approves Pfizers Nyvepria, a biosimilar to Amgens Neulasta.
Federal Register notice: FDA seeks comments on an information collection revision for Medical Device User Fee Cover Sheet, Form FDA 3601and Device Fac...