FDA Stresses Careful Approach For New Cellular, Gene Therapies

摘要

Firms are advised to use an incremental approach to developing product characterization tests for investigational cellular and gene therapies because they are complex and can present significant challenges in establishing potency assays, a new draft guidance says. "In early clinical phase investigations, it may not be possible to meet all of the requirements ... for licensed biological products," the FDA says in the draft guidance. "Nonetheless, you must submit data to assure the identity, quality, purity and strength (21 CFR 312.23(a)(7)(i)) as well as stability (21 CFR 312.23(a)(7)(ii)) of products used during all phases of clinical study," the agency tells manufacturers.