21 CFR § 314.120 Applications for FDA Approval to Market a New Drug

§ 314.120 [Reserved]

Current through Sep 8, 2026 · Read all of Part 314

⚠ 4 pending changes to Part 314

← § 314.110 Complete response letter to the applicant.§ 314.122 Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed. →