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1315. Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics

1316. Center for Devices and Radiological Health (CDRH) appeals processes: Guidance for industry and Food and Drug Administration staff

1318. Current good manufacturing practice and preventive controls, foreign supplier verification programs, intentional adulteration, and produce safety regulations: enforcement policy regarding certain provisions

1319. Initiation of voluntary recalls under 21 CFR Part 7, subpart C: guidance for industry and FDA staff