Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance
The FDA intends to award a 1-year base, sole source, firm-fixed-price order to DIA Inc. in Washington, DC, without competitive proposals. This noncompetitive action is justified by DIA’s unique capability, institutional knowledge, and ability to meet time-sensitive mission requirements. The contractor will develop and deliver a professional certification program on FDA generic drug regulation and regulatory reliance for foreign regulatory staff in low- and middle-income countries. The program must issue IACET Continuing Education Units and require deep expertise in generic drugs, international harmonization, and established relationships with foreign National Regulatory Authorities. The anticipated period of performance is a 1-year base.