Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs

Description

This guidance pertains to submissions of promotional materials for human prescription drugs (drugs) to the Food and Drug Administration (FDA or Agency) made by manufacturers, packers, and distributors (firms), whether the applicant or an entity acting on behalf of the applicant. Specifically, this guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER). This guidance also explains certain aspects of electronic submission of promotional materials in module 1 of the electronic common technical document (eCTD), using version 3.3 or higher of the us-regional-backbone file.

Scope & Applicability

Regulatory Context

• 21CFR202.1§ 202.1 Prescription-drug advertisements.

  Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →

• 21CFR601.41§ 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

  FDA may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, tRead full regulation →

• 21CFR314.510§ 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

  FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predicRead full regulation →

• 21CFR601.12§ 601.12 Changes to an approved application.

  (a) General.Read full regulation →

• 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.

  (a) Changes to an approved NDA.Read full regulation →

• 21CFR314.81§ 314.81 Other postmarketing reports.

  (a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 21CFR314.550§ 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, inteRead full regulation →

• 21CFR601.45§ 601.45 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 advertisementsRead full regulation →

• Advertising & Promotional Labeling/Drugs/Biological Products

  CSL Behring

  2025-09-16

• False & Misleading Claims/Misbranded

  Aytu Biopharma

  2025-09-16

• False & Misleading Claims/Misbranded

  Novo Nordisk Inc.

  2025-09-16

• False & Misleading Claims/Misbranded

  Eli Lilly and Company

  2025-09-16

• False & Misleading Claims/Misbranded

  Alora Pharmaceuticals

  2025-09-16

• False & Misleading Claims/Misbranded

  Sprout Pharmaceuticals, Inc.

  2025-06-10

• False & Misleading Claims/Misbranded

  Sarfez Pharmaceuticals, Inc.

  2025-05-20

• False & Misleading Claims/Misbranded

  Aurora Pharmaceutical

  2025-03-11

• False & Misleading Claims/Misbranded

  Elanco Animal Health

  2025-03-11

• False & Misleading Claims/Misbranded

  Boehringer Ingelheim Animal Health USA

  2024-03-12

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