Submit post-approval promotional materials at least 30 days before use
Rule
For a biological product approved under accelerated approval, once more than 120 days have passed since marketing approval, the applicant must submit each new promotional labeling item or advertisement to FDA at least 30 days before its intended initial dissemination or publication, unless FDA has instructed otherwise.
Check
For any promotional labeling or advertisement first used more than 120 days after approval, verify FDA received a copy at least 30 days before that first use/publication date. A violation is initial dissemination or publication occurring less than 30 days after FDA submission (or without submission), absent documented FDA instruction excusing the requirement.
Escalate when
Escalate if the submission date, the intended/actual first dissemination date, or the existence of an FDA instruction altering the 30-day requirement cannot be confirmed.
Where this comes from
21 CFR 601.45. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.
…01.45 Promotional materials. For biological 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 601.45
- 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
- d9573263989a646e8cdea14f…