Attachment VII - Drug Product Labeling Submission and Review Process Use Case.docx

SOLICITATION NO.: FDA-20-SOL-1223486

Attachment VII: Drug Product Labeling Submission and Review Process Use Case

Drug Product Labeling Submission and Review Process Use Case

A company submits a new drug application for an injectable drug product. The application includes the 1) proposed prescribing information in both a Word file and XML file, and 2) image of the proposed container label in PDF, and 3) image of the carton labeling in PDF.

The FDA reviewer downloads the submitted electronic files containing the proposed prescribing information and images of the container label and carton labeling. The reviewer analyzes the prescribing information and images against a list of applicable statutes, regulations, standards, FDA guidance for industry, and best practices for patient safety to identify proposed content that may contribute to medication errors (e.g., error prone abbreviations, unclear preparation and dosing instructions, discordant product strength and units of measure, confusing packaging, lack of prominence for the product name, missing storage information, no differentiation for product strengths, and missing or uninterpretable lot numbers, National Drug Code [NDC] numbers or linear barcodes). The reviewer also compares the proposed container label and carton labeling against currently marketed products to avoid look-alike labeling that may contribute to medication errors.

The reviewer then creates a written document that summarizes findings (including identified deficiencies and inconsistencies) from the review of the proposed prescribing information and images of the container label and carton labeling, and provides recommendations for the company. The company then considers FDA’s recommendations and submits revised labeling to address the deficiencies and inconsistencies. The reviewer compares the revised labeling with the original or previously submitted labeling, analyzes the revised labeling, and notifies the company if the revised labeling is acceptable or if additional revisions are needed.

FDA management periodically runs administrative and metric reports to track workload, frequently identified labeling deficiencies or inconsistencies, number and types of products or labeling materials reviewed, performance, etc.