The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more
The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials...more
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and...more
FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance...more