FDA and the Center for Research on Complex Generics (CRCG) will host a free public webinar on Dec. 6, 2022: Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned
The goal of this webinar is to provide an overview of the regulatory framework, scientific concepts, product-specific challenges, and best practices related to development of complex generic drug products that are either required or recommended to have the same formulation as their respective reference listed drugs (RLDs). This information will provide a better understanding for the considerations that go into developing appropriate formulations, as well as best practices to present and support a formulation assessment that can reduce the time to potential product approval. The one-day webinar will include five sessions composed of presentations from FDA and the pharmaceutical industry followed by panel discussions to answer attendee questions.
This workshop is FREE. REGISTER now.