Parts 10 through 16 apply to hearings relating to new drugs under section 505 (d) and (e) of the act.
21 CFR Part 314 · Applications for FDA Approval to Market a New Drug
§ 314.201 Procedure for hearings
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 50 FR 7493 22 Feb 1985