US FDA Calls Biologic Makers to ‘INTERACT’ With New Program

The Agency has launched the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) program to help sponsors plan development projects more effectively.

The program is being introduced by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) to allow potential sponsors to engage with Agency staff and obtain advice on a specific topics or issues critical to early product development.

The discussions aim to advance product development by answering sponsors’ questions, removing roadblocks, and creating a clearer route to getting products to patients.

“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,” CBER director Peter Marks said.

“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.”

According to the Agency, questions arising during the INTERACT meetings will focus on the requirements for preclinical testing of a product, aspects of manufacturing required for first–in–human trials, initial clinical development strategies, and device or assay design considerations.

Marks added: “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”

The INTERACT program will replace the current pre- pre-investigational new drug (IND) meeting program for all biologic products. Further details of the new program will be revealed over the coming months.