RMAT Designation Enables Critical Manufacturing Discussions – FDA's Marks
Designation of cell and gene therapies as regenerative medicine advanced therapies is enabling deeper interaction with the US FDA on manufacturing challenges, says the head of the agency's biologics center.
You may also be interested in...
Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.
HHS agencies look to build on COVID-19 experience by developing quicker public/private responses to pandemics and supply chain threats.
Federal agency seeks dialogue with industry on how to enable surge capacity for pandemic vaccines without cutting back on other production.One key factor: workforce development.