Biosimilar to Remicade
Learn how the Food and Drug Administration (FDA) plays a critical role in the oversight of many medical devices used commonly in dermatology.
To help providers have a greater understanding of the efforts of the FDA to ensure all drugs are of pharmaceutical quality, Michael Kopcha, Ph.D., RPh, director of the FDA’s Office of Pharmaceutical Quality presented on the topic during the American Academy of Dermatology’s Annual Meeting in Washington, D.C.
Laura Marquart, M.D., FAAD, medical officer with the FDA’s Center for Devices and Radiological Health (CDRH), reviewed how the FDA approaches, reviews, and approves medical devices integral to dermatologic care at the American Academy of Dermatology’s annual meeting in Washington, D.C. Learn how this process can affect patient care in this article.
Biologic tildrakizumab-asmn approved with suffix as differentiator from future biosimilar versions.
Congress has proposed two bills that are designed to promote a "scientific exchange" between drug manufacturers and physcians. As a result, drug manufacturers may be able to share clinical data and non-FDA-approved uses of drugs with healthcare providers in the future.
Evolus (DWP-450; prabotulinumtoxinA) and Bonti (EB-001A; BoNT/E) report positive progress towards commercialization.
The FDA is exploring ways to prevent long-term drug shortages and allow more drug importation so patients have access to medically necessary drugs.
The Food and Drug Administration is in the process of evaluating scientific data on the safety of probiotics and postbiotics in cosmetics, said Linda Katz, M.D., director of the Office of Cosmetics and Color for the FDA.