Regulatory Blog

Next-generation sequencing (NGS) has become an essential tool in antiviral drug development, enabling detailed analysis of viral genetic changes and the identification of resistance-associated variants. Compared with traditional sequencing methods, NGS generates extensive sequence data that provides a deeper understanding of viral populations throughout clinical development. To promote consistent and high-quality regulatory submissions, the U.S. Food and Drug Administration (

For generic drug developers, receiving tentative approval (TA) for an Abbreviated New Drug Application (ANDA) is a major milestone—but it is not the end of the regulatory journey. Moving from tentative approval to final FDA approval requires careful planning, timely submissions, and technically compliant study data. To support applicants, the FDA has issued two complementary guidance documents: ANDA Submissions — Amendments and Requests for Final Approval to Tentatively App

The U.S. Food and Drug Administration (FDA) has released the latest version (v6.0) of the Study Data Technical Conformance Guide in...