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The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the...more
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and...more
The US Court of Appeals for the Fourth Circuit decision in US ex rel. Sheldon v. Allergan Sales, LLC acknowledges the complexity of price calculations under the Medicaid Drug Rebate Statute and highlights the importance of...more