The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has published two internal policy guides for staff outlining procedures for placing a clinical study on hold and addressing the administrative processing of biologics license applications (BLAs) and new drug applications (NDAs).
Both sets of policies went into effect on 22 September 2023.
Processing clinical holds
Standard operating policy and procedures (SOPP) 8201, version 8, covers the administrative processing of clinical holds. Under 21 CFR 312.12, clinical holds are ordered by FDA when a clinical investigation reveals information that indicates a proposed treatment poses an « unreasonable and significant risk of illness or injury » while under 21 CFR 312.42(e), the clinical hold can be lifted if the agency is satisfied that these risks have been addressed.
Under the policy, CBER will review all investigational new drug applications (INDs) within 30 days of receipt and contact the sponsor when a clinical hold is being imposed. The policy states that “where it is determined there are grounds for imposing a clinical hold, regulations require that, unless patients are exposed to immediate and serious risk, FDA will attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order.”…
