CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed.
Approvals of individualized gene therapy approvals at the US Food and Drug Administration could speed up using a 510(k)-like process under consideration.
Peter Marks, director of the Center for Biologics Evaluation and Research, said the FDA needs a workable pathway not requiring...
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
