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PhRMA says FDA should change a proposed survey on promotional implications of proprietary drug names if it intends to proceed with...[ Price : $8.95]
FDA approves a Samsung Bioepis supplemental BLA for a 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referen...[ Price : $8.95]
Federal Register notice: FDA announces its process for making available guidance documents related to the coronavirus public healt...[ Price : $8.95]
FDA accepts for priority review a Jazz Pharmaceuticals NDA JZP-258 (oxybate), an investigational drug for treating cataplexy or ex...[ Price : $8.95]
FDA clears an Align Technology 510(k) for the iTero Element 5D Imaging System.[ Price : $8.95]
Gilead asks FDA to rescind its orphan drug designation of the companys remdesivir as a potential treatment for Covid-19.[ Price : $8.95]
FDA warns California IVF Fertility Clinic about significant deviations from HCT/Ps regulations.[ Price : $8.95]
FDA issues an immediately-in-effect guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-201...