For drug products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisements, intended for dissemination or publication within 120 days following marketing approval. After 120 days following marketing approval, unless otherwise informed by the agency, the applicant must submit promotional materials at least 30 days prior to the intended time of initial dissemination of the labeling or initial publication of the advertisement.
21 CFR Part 314 · Applications for FDA Approval to Market a New Drug
§ 314.640 Promotional materials
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FDA guidance that cites § 314.640
- Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry draft 2 Jun 2026
- Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers draft 8 Jul 2024
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs 11 Apr 2022
- Product Development Under the Animal Rule 2 Oct 2015
Amendment history
Federal Register documents that created or amended this section.
- 50 FR 7493 22 Feb 1985