In order to ensure the safety, effectiveness, and availability of the biological products provided to patients, CBER works to continuously improve review efficiency and quality, as well as the quality of its regulatory efforts and interactions. It does this by increasing its staff’s understanding of the industry and its operations, and has initiated various training and development programs in order to do so.
For more than a decade, CBER has been working to enhance:
In 2005, CBER's Regulatory Site Visit Training Program (RSVP) was enacted with the goal of helping to achieve and enhance the items listed above.
On September 23, 2004, the FDA announced the initiation of RSVP and asked interested parties to submit a request for participation by October 25, 2004. The program took effect on November 22, 2005, and every year since then CBER has published a notice in the Federal Register to announce RSVP and invite interested firms to participate.
The program aims to give certain CBER staff an opportunity to directly observe routine manufacturing practices by allowing CBER regulatory review, compliance, and other relevant staff members to visit biologics facilities. In turn, CBER’s hope is that these visits help its staff better understand the biologics industry, its challenges, and its operations.
Facilities are selected based upon the coordination of CBER’s priorities for staff training and RSVP’s limited resources. “In addition to logistical and other resource factors to consider, a key element of site selection is a successful compliance record with FDA or another Agency.”
After a sites are selected, small groups of CBER staff may observe operations of biologics establishments over a predetermined and agreed upon period of time. Observations may include various operations within the facility, such as regulatory affairs operations, packaging facilities, and quality control and pathology/toxicology laboratories. In addition, CBER states that “these visits, or any part of the program, are not intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but are meant to improve mutual understanding and to provide an avenue for open dialogue between the biologics industry and CBER.”
Biologics facilities that are interested in participating should submit either an electronic or written request to the FDA’s Division of Dockets Management. Requests should include a description of the facility relative to products regulated by CBER, and should specify the physical address(es) of the site(s) being offered. Facilities that have previously submitted requests to participate in RSVP and are still interested in contributing, can renew their request through a submission to the Division of Dockets Management.
Participation requests are due to CBER by March 3, 2016, so interested facilities should submit their request as soon as possible.
Are you a biologics facility seeking to become compliant with FDA’s regulations? Are you in the process of developing a biological product, or seeking FDA approval for a product that is regulated by CBER? We can help. Using our unique approach to FDA, we can help you attain the desired outcome for your product. To learn more about how we can help you, contact us today.