Streamlined approach could reduce time and cost to bring new cancer drugs into human trialsSilver Spring, Md., May 29, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a <a href="https://www.globenewswire.com/Tracker?data=WENO3-F96CvJXPYy8IEUZYnxs3cyiQtoj-c6u0FBI3vBfCYciSM-zt7FiiXmOafSaENJ0pFe6FucCQV-csZCq9xlClpJdKO8GiR0jjxa88KVBTbYsUojkbIW1ms7c3-mGXwEFBvnYavIygm-wXOQEx6-mkZoJ_9798PI17bJtoy_zEuQoUBa_yJB7VJJB-7qoVnmjY3AltVVNey8n9FqYbkqUGg-fUk77bChDl2b68VRmQ1AAFRdbakZdPW1p0fM93oR1PjXDAzMo7m9b1s-MrLbc8EsTIk2XezPcDKzpMU=" rel="nofollow" target="_blank" title="draft guidance">draft guidance</a> to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs. “This draft guidance not only supports the FDA’s commitment to expedite regulatory pathways for meaningful treatments but also fulfills the agency’s promise to reduce the use of animal testing during drug development,” said FDA’s Oncology Center of Excellence Director Angelo de Claro, M.D. “With recommendations for eliminating unnecessary animal testing, using a single relevant species instead of two, or replacing animal studies with evidence-based approaches — as outlined in this draft guidance — the FDA is advancing a more efficient drug development process.” When finalized, the guidance will provide recommendations for general toxicology studies, including when animal testing may be unnecessary because there is no binding or pharmacologic activity. In some cases, the guidance recommends using rodent studies only or replacing three-month non-human primate studies with a weight-of-evidence risk assessment. That assessment may include New Approach Methodologies, as appropriate. New Approach Methodologies were defined in a <a href="https://www.globenewswire.com/Tracker?data=17rl6ABf82dXs7N813bJ5cqNZ-Ny0QwOJ3fIbeNIj6Fm2UYc6USlKRYnAf7VMJXs3ft38_b46v-B7488eC1D60z6JPOfG_pZhcP8WXXWlTYCoKypM7StE7Hn-s-0z1tYSV-e5YJUoey5spTkiOeJpw-JPFrV0I0R8oQn9MjhoLLfSZwHdqmdhNSVfr6l6Czc9_xwu5DWAGxgrr8D2tggsw==" rel="nofollow" target="_blank" title="recent FDA webpage">recent FDA webpage</a>. This draft guidance, “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products,” is part of the FDA’s broader work to reduce the estimated 10 to 12 years it can take to bring new drugs from discovery to patients. It builds on FDA data analysis of general toxicology studies and practices developed during the COVID-19 pandemic to reduce the use of non-human primates. It also supplements guidance issued by the International Council for Harmonisation (ICH) and <a href="https://www.globenewswire.com/Tracker?data=Le8C_V2t3P2E3pPm-hXK62eJ7mhj7Za3rYJu-Rb8boaBfXN-3vjfIOEHPeVyLDZgjG0OqthwD2O22ixOesTF4D1VyNNZNN5R_dFLFTjsjqmYHxgn7_PE1cWGZjLTcHZv4cFhaTMAjn82xzi1bId3aZSEu1o4Li7IgWenMhm9B6hq-5WuCPKKM1oZCIhDS0Vc9OItgMr3UjJnyhQ0aN9G2uO_7gBcWHDARJgQyDCeyAduFDiWIT8oPjNj6BCE8oRlAgnoxIBZUp3Kd2QRWoSMsZmlKDhrAT-Mnsne_W9eKaM=" rel="nofollow" target="_blank" title="FDA guidance">FDA guidance</a> on nonclinical studies for oncology therapeutic radiopharmaceuticals.   The FDA requests that public comments on the draft guidance be submitted by July 30, 2026. The agency will review and consider comments received before finalizing the guidance. Related Information <hr /> <ul><li><a href="https://www.globenewswire.com/Tracker?data=qSimeXE-zxg_PosEfMdtY3GYuJBSDwhXJH6ELbNLOnLYNEMqMaLLMnmtpWVsAR7k1yfhW71cnEHZ1jMrd0-iwQrH-YZz_SQi7dDQHjGoaIygwAGXXJfNIOb0wBH70-mnChjcDnkRsI4dslB0rXCgijKSbj8MmirFb-Kk91TUvO3UbgVg4SGV_sv70sVgiuk4PZLMGruKgoO5qJLVcLqPolqkMZI_HCpLFbwGhKSrPOQ=" rel="nofollow" target="_blank" title="Oncology Center of Excellence Guidance Documents">Oncology Center of Excellence Guidance Documents</a></li></ul> ### The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. Contact Info U.S. Food and Drug Administration <a href="https://www.globenewswire.com/Tracker?data=hfn0bMONDc_Gd3tONmQkdDIkjNwc1jMHJ7MpR_RPTadMnPecR89zLeRwkWm03-3s8VZC7PFc58kdHn2-p-YlIhLzRqhtk8dwwckZ0MdAcdZK9UI7Df_MiL5owec5J3OK" rel="nofollow" target="_blank" title="FDAPressAlerts@fda.hhs.gov">FDAPressAlerts@fda.hhs.gov</a> +1 202-690-6343 <img alt="" src='https://ml.globenewswire.com/media/YTBlYWFhYzctOTFiOC00NmUxLTkzN2ItNmYzODY4ZDRkZDcyLTUwMDE1NDE1NC0yMDI2LTA1LTI5LWVu/tiny/FDA.png' referrerpolicy='no-referrer-when-downgrade' />

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

Latest news from the world of business and finance – both local and global

MONEY FM 89.3 is Singapore's first and only Business and Personal Finance station, featuring local and international business and financial news.

MONEY FM 89.3

Discover newsletters from our DJs on LinkedIn