FDA In Brief: FDA announces program to enhance early communications with biological product developers
June 22, 2018
“We know that academic investigators, small and medium enterprises, and sometimes even large companies can have questions regarding the path from preclinical to clinical development for biological products – particularly those that raise new regulatory questions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “As part of our commitment to help accelerate the development and approval of innovative medical products, the FDA has implemented the INTERACT meeting program, designed to foster timely engagement with CBER on issues critical to early product development. It’s also aimed at helping innovators meet the FDA’s science-based requirements more effectively. These meetings have the potential to help streamline development by helping sponsors avoid unnecessary preclinical or other preparatory studies or plan initial clinical development strategies.”
The FDA’s new INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program was created to facilitate early interactions between sponsors and CBER staff. It replaces the existing CBER pre- pre-Investigational New Drug (IND) meeting process for all products across the center. These meetings will allow sponsors that are not yet ready for a pre-IND meeting to receive feedback from CBER. INTERACT meetings will enable sponsors to engage with the FDA early in the development process and obtain advice on a wide range of development-related topics. INTERACT meetings can be used to clarify CBER’s expectations regarding product development programs and to help facilitate more efficient product development.
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, products that give off electronic radiation, and for regulating tobacco products.