Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers
FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.
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FDA Signals Willingness To Grant Regulatory Flexibility For Cell and Gene Therapy Products In CMC Reviews
US FDA official says that the complexities involved in producing cell and gene therapies necessitate a “new manufacturing paradigm” in evaluating biologics license applications. For such therapies, the agency is willing to grant regulatory flexibility in certain areas of its chemistry, manufacturing and controls review.