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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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.
US FDA investigators are more likely to cite cell and gene therapy manufacturers for facilities and production deficiencies, agency says, while industry reports difficulties complying with drug GMP requirements that are not always applicable to cell and gene therapies.