Fashionably Early: When to Make Your Case to CMS

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...

More from Platform Technologies

More from Advanced Technologies

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 

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.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 

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.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.