On June 21, the U.S. Food and Drug Administration (FDA) finalized industry guidance pertaining to the requirements and recommendations for manufacturers, packers, and distributors when submitting promotional materials for prescription drugs to (i) the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and (ii) the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER).
The guidance sets forth general information on how the FDA interprets and intends to implement the electronic submission requirements of section 745A(a) of the US Federal Food, Drug, and Cosmetic Act (FDCA). Importantly, effective June 24, 2021, paper copies will no longer be accepted for certain types of promotional materials that fall under section 745A(a) of the FDCA and must be submitted electronically in eCTD format using version 3.3 or higher of the us-regional-backbone file.
Pursuant to the guidance, the FDA recommends that all promotional material submitted for review should be in the same format as provided to the end-user audience. The FDA encourages firms to submit promotional materials directed to health care professionals separately from submissions of promotional materials directed to consumers. If promotional materials are directed to both consumers and health care professionals, then firms should identify the audience type based on the end-user for the bulk of the information. In order to assist firms with these new requirements, the FDA’s guidance provides examples to illustrate “appropriate” electronic submissions of promotional materials.
For the full text of the FDA’s guidance document, see “Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs”