For Cell And Gene Therapies, Expedited Designation And Complex Questions Improve FDA Meeting Chances
Executive Summary
Designation as a regenerative medicine advanced therapy or breakthrough therapy ‘dramatically increases’ the likelihood of getting a meeting with the agency, Office of Tissues and Advanced Therapies’ Wilson Bryan says; more complex and innovative products, and more challenging questions, also are likely to win sponsors an audience with the FDA.
You may also be interested in...
US FDA’s Oncology Divisions Have Been Providing Live Meeting Minutes For Years. Will Others Follow?
Oncology division officials summarize the agreements and discussions reached during formal meetings so there are no misunderstandings later. Sponsors want the practice used more widely by the FDA.
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.