Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance

The U.S. Food and Drug Administration (FDA) is conducting market research for obtaining Global Abbreviated New Drug Application (ANDA) Training Program services. The purpose of this Sources Sought Notice (SSN) is to identify potential business sources and small business sources capable of providing the full range of services described. The training program will cover the regulatory framework for generic pharmaceuticals, including the ANDA process, bioequivalence, and global reliance. Interested parties are encouraged to respond to this SSN by providing the requested information, including a completed Vendor Feedback Form, tracked changes/comments on the Draft Statement of Work, and a Capability Statement. • The FDA is seeking a training program that covers the regulatory framework for generic pharmaceuticals. • The program should include modules on the ANDA process, bioequivalence, and global reliance. • The training program should be designed to provide a comprehensive overview of the regulatory framework for generic pharmaceuticals. • The FDA is seeking responses from potential vendors that can provide the full range of services described in the SSN.