FDA clears a CivaTech Oncology 510(k) for its CivaDerm, a radiation therapy bandage designed for intraoperative or surface radiation to treat skin can...
FDA posts an 11-item Form FDA-483 to U.S. Specialty Formulations after concluding an inspection of its Bethlehem, PA manufacturing facility.
A new FDA literature review on dental amalgam safety finds no sufficient evidence of a relationship between clinically detectable adverse health outco...
Federal Register notice: FDA announces the fee rate of $2,167,116 for using a pediatric disease priority review voucher for fiscal year 2020.
Federal Register notice: FDA announces the fee rate of $2,167,116 for using a material threat medical countermeasure priority review voucher for fisca...
The government charges Avanir Pharmaceuticals and four individuals for paying kickbacks to a physician to induce prescribing of its drug Nuedexta.
FDA posts a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.
FDA Review posts the Federal Register notices for the week ending 9/27/2019.