CBER Implements Pre-Clinical Meeting Program For Biologics, Gene Therapy Sponsors
INTERACT program will allow sponsors to ask FDA questions about manufacturing and other technical issues to help streamline development.
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Regenerative Medicines: Development Slowed By Lack of Standardization, Regulatory And Manufacturing Challenges
A Government Accountability Office report identifies 10 policy options aimed at speeding development and boosting the use of regenerative therapies, but breaks little new ground, highlighting the continuing difficulties in the space.
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.
Regulators in high-income countries have a responsibility to help health authorities in low- and medium- income countries develop regulatory frameworks for cell and gene therapy products to ensure these treatments are available to all, asserts the US FDA’s biologics center’s director.