Platform Technology Designation A Gene Therapy Opportunity, OTP Director Verdun Says
The new designation could streamline development of multiple products that use the same backbone, said Nicole Verdun, director of the US FDA’s Office of Therapeutic Products.
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CBER’s director says manufacturing and regulatory issues need to be resolved to ensure the gene therapy sector thrives.
Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.
Pharmacy benefit managers are increasingly making money off new types of fees tied to list prices, drug industry lobby says, highlighting importance of delinking all PBM compensation from the cost of medicines. Most Congressional proposals in play do not include delinkage provision.