Today, the U.S. Food and Drug Administration and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding regarding medical product development and assessment. This builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.
President Trump has signed a bill into law that extends a program funding medicines for pets and livestock. The legislation, collectively known as the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, or ADUFA, charges fees for drug and device applications and uses that money to speed up their review. That way, products can head to market faster, and animal owners can have less expensive or more effective drugs to use on animals who fall ill.
The U.S. House of Representatives Committee on Energy and Commerce has moved to advance the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (H.R. 5554) and included language that would expand conditional approvals beyond minor uses and minor species.
Dr. Claire Pomeroy, Founding Director Emeritus of Expanesthetics and President of the Lasker Foundation, offers important context in the leading Capitol Hill publication as Congress debates funding levels for science and medical research.
The Defense Department and Food and Drug Administration have launched a joint pilot program to prioritize efficiently developing safe and effective medical products to save the lives of U.S. warfighters.
EDITOR'S NOTE: One of Expanesthetics' programs may qualify for this DOD/FDA program, post-pilot.