Active Solicitation · DEPT OF DEFENSE
AI Summary
The Department of Defense's Defense Health Agency requires services to manage and process electronic structured product label submissions to the FDA. This involves initial labeling and changes for two licensed New Drug Application products, adhering to HL7 standards. Interested bidders should prepare to meet these regulatory requirements.
Office of Regulated Activities of the DHA R&D – Medical Research and Development Command (MRDC) has a requirement to manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA. Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. The DHA R&D – MRDC currently has 2 licensed New Drug Application (NDA) products which require SPL submissions for up to 5 levels of primary and secondary labeling.
STRUCTURED PRODUCT LABELING (SPL) HT9426-26-Q-E022 is a federal acquisition solicitation issued by DEPT OF DEFENSE. Review the full description, attachments, and submission requirements on SamSearch before the response deadline.
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