Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance

Health and Human Services, Department of

Silver Spring, MD

In plain English

The FDA wants a one-year professional certification program for regulatory staff, reviewers, and policymakers in low- and middle-income countries. The program will cover generic drug regulation, ANDA submissions, and regulatory reliance, and must issue IACET continuing education units. FDA intends to award a sole-source, fixed-price order to DIA Inc.; this notice is not a request for competitive proposals.

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