CBER Launches new Program for Early Interaction With Biologics Developers
Posted 22 June 2018 | By
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) on Friday announced it is launching a new program for early meetings with biologics developers.
The new program, called INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs), replaces CBER's existing pre- pre-investigational new drug (IND) meeting program.
"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 CBER Director Peter Marks.
According to Marks, the new program will be better tailored to providing input to biologics developers at early stages of development and will help sponsors plan their development programs to gather evidence needed for FDA approval more effectively.
The INTERACT program is open to all products regulated by CBER and allows for developers to get feedback before they are ready to initiate a pre-IND meeting.
FDA also says the program can cover a "wide variety of development-related topics" such as requirements for preclinical testing, manufacturing requirements ahead of first-in-human trials, early clinical development strategies or device and assay design questions.
But FDA notes that the INTERACT program is not meant to replace any of the various formal product-specific meetings that occur later in development.
Biologics developers are instructed to contact the appropriate CBER review division of its Manufacturers Assistance and Technical Training Branch if they have questions on what type of meeting they should request and what information they should be prepared to submit ahead of an INTERACT meeting.
CBER says it plans to post more specifics about the INTERACT meeting program in the coming months.