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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs April 2015

Draft

Not for implementation. Contains non-binding recommendations.

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

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This draft guidance pertains to submissions of promotional materials for human prescription drugs (drugs)to the Food and Drug Administration (FDA or the Agency) made by manufacturers, packers, and distributors (firms), whether the applicant or an entity acting on behalf of the applicant. Specifically, this draft guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and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), and 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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.