The U.S. Army Medical Materiel Development Activity’s (USAMMDA) is seeking entities interested in providing support and services assisting in the development of the malaria drug, Tafenoquine.
The Request for Information (RFI) is seeking entities interested in advancing Tafenoquine (TQ) as a malaria prophylactic drug for FDA-TGA (Food and Drug Administration-Therapeutic Goods Administration) approval first in Australia and then in the United States.
Specific support and services may include organization of meetings and provision of Regulatory support and strategy, development of clinical protocols, statistical or data management services, medical writing and electronic publishing, program management, provision of tropical medicine and clinical pharmacology expertise to an Integrated Product Team (IPT), and the preparation of required Regulatory documents to support the filing application.
Further details are available under Solicitation Number: W81XWH-14-RFI-00TQ.