FDA News

FDA launches new early meeting program for biologic developers

The FDA hopes a newly launched program will facilitate early meetings with biologic developers, according to a release from the agency.

Operating as part of the agency’s Center for Biologics Evaluation and Research (CBER), the new program — known as INTERACT, short for INitial Targeted Engagement for Regulatory Advice on CBER ProducTs — will replace the current pre-pre-investigational new drug meeting process.

“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,” Peter Marks, MD, PhD, director of CBER, said in a press release. “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.”

The FDA said the new INTERACT program will help developers receive feedback on a potential product even if they are not fully prepared for a pre-meeting.

The meetings will allow developers to receive guidance from the agency and help them understand what CBER expects very early in the process, easing the course of development, according to the release.

“It’s also aimed at helping innovators meet the FDA’s science-based requirements more effectively,” 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.”

Disclosures: Marks is employed by the FDA

The FDA hopes a newly launched program will facilitate early meetings with biologic developers, according to a release from the agency.

Operating as part of the agency’s Center for Biologics Evaluation and Research (CBER), the new program — known as INTERACT, short for INitial Targeted Engagement for Regulatory Advice on CBER ProducTs — will replace the current pre-pre-investigational new drug meeting process.

“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,” Peter Marks, MD, PhD, director of CBER, said in a press release. “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.”

The FDA said the new INTERACT program will help developers receive feedback on a potential product even if they are not fully prepared for a pre-meeting.

The meetings will allow developers to receive guidance from the agency and help them understand what CBER expects very early in the process, easing the course of development, according to the release.

“It’s also aimed at helping innovators meet the FDA’s science-based requirements more effectively,” 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.”

Disclosures: Marks is employed by the FDA