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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Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
Productivity may suffer under coronavirus-mandated telework despite workforce diligence, experts say.
Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.