WASHINGTON – The Consumer Healthcare Products Association (CHPA) has released a statement following the U.S. Food and Drug Administration’s (FDA) recent announcement outlining scientific and technical steps to transition from animal testing to New Approach Methodologies (NAMs) for safety assessments of drug products.
CHPA statement
“CHPA applauds FDA’s continued efforts to modernize regulatory science and is encouraged by its recent announcement as validated NAMs have the potential to not only replace animal testing requirements for safety assessment but also to provide more timely and predictive information relevant to human exposures. We are enthusiastic about FDA considering pre-existing, real-world safety data from other countries with comparable regulatory standards, as well. We look forward to working collaboratively with FDA and other stakeholders on this important scientific and regulatory paradigm shift that will accelerate Americans’ access to new treatments and expand access to disease prevention options.”
