After 120 days post-approval, submit promo materials 30 days before use
Rule
For a drug approved under the accelerated approval subpart, once more than 120 days have passed since marketing approval, the applicant must submit each new item of promotional labeling or advertisement to FDA at least 30 days before its intended initial dissemination or publication, unless FDA has otherwise informed the applicant.
Check
For promotional materials used more than 120 days after approval, verify the piece was submitted to FDA at least 30 days before its first use/publication date. A violation is initial dissemination less than 30 days after (or without) FDA submission.
Escalate when
Escalate if it is unclear whether FDA has instructed the applicant to follow a different submission timeline, or whether the 120-day post-approval threshold has been reached for this product.
Where this comes from
21 CFR 314.550. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.
… § 314.550 Promotional materials. 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. …
- Document
- 21 CFR 314.550
- Version
- 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
- Retrieved
- 2026-09-21 from www.ecfr.gov
- Fingerprint
- f6b458c68a5547f47c650231…