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FDA posts a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.
A new FDA literature review on dental amalgam safety finds no sufficient evidence of a relationship between clinically detectable adverse health outco...
FDA Review posts the Federal Register notices for the week ending 9/27/2019.
FDA Review posts product approval summaries for the week ending 9/27/2019.
Federal Register notice: FDA makes available a final guidance on Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st...
CDERs Office of Prescription Drug Promotion cites a Kowa Pharmaceuticals America direct-to-consumer patient testimonial video montage about cholestero...
Federal Register notice: FDA makes available a draft guide on demonstrating bioequivalence for soluble powder oral dosage form products and Type A med...