Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance

Notice ID:FDA-OC-2026-135574

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.

Department/Ind.Agency Subtier Office
HEALTH AND HUMAN SERVICES, DEPARTMENT OF FOOD AND DRUG ADMINISTRATION FDA OFFICE OF ACQ GRANT SVCS
  PSC   R408 SUPPORT- PROFESSIONAL: PROGRAM MANAGEMENT/SUPPORT
LOCATION: Not Given
Primary Contact
Lawrence Edelmann
Not Given

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