C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

21 C.F.R. § 314.550

Promotional materials

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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.

Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2023–2023 · leading case: All. Hippocratic Med. v. FDA, 78 F.4th 210 (5th Cir. 2023).
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All. Hippocratic Med. v. FDA, 78 F.4th 210 (5th Cir. 2023). “Moreover, the letter only approved the Risk Evaluation and Mitigation Strategy proposed in Danco’s 2008 Supplemental Application— it did not re-approve the drug apart from Subpart H. In fact, the letter recognized the need for continued compliance with the conditions “required…”
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