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.
The new regenerative medicine advanced therapy designation is turning out to offer a major benefit of deeper regulatory interactions around manufacturing issues, according to Peter Marks, director of FDA's Center for Biological Evaluation and Research.
Like the US breakthrough designation, RMAT offers early and frequent opportunities for exchanges with regulators, with the goal of quicker...
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
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.
