Providing regulatory submissions in electronic and non-electronic format: promotional labeling and advertising materials for human prescription drugs
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Advertising -- legislation & jurisprudence Advertising -- standards Drug Approval Drug Labeling -- legislation & jurisprudence Drug Labeling -- standards United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- 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. For the purpose of this guidance, the term promotional materials collectively refers to promotional labeling and advertising materials, regardless of the format, manner, or medium by which they are presented. Promotional materials may include, but are not limited to, television advertisements (ads), brochures, booklets, detailing pieces, internet websites, print ads, exhibits, sound recordings, and radio ads.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (ii, 37 pages)).
- NLM Unique ID:
- 9918452382106676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918452382106676