Ramsey Baghdadi
After your first visit with the Food and Drug Administration in the Washington, DC suburbs to discuss your new product...
Manufacturers used to look at Medicare coverage as an afterthought to FDA approval. Now, CMS has a simple message for biopharmaceutical companies: plan ahead. CMS senior officials explain what manufacturers should be thinking about when they come to the agency about reimbursing new products.
Ramsey Baghdadi
After your first visit with the Food and Drug Administration in the Washington, DC suburbs to discuss your new product...
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.