For INTERACT meetings, official meeting minutes will not be issued to sponsors. Additionally, any meeting minutes prepared and sent to CBER by the Sponsor will not be reviewed or evaluated for accuracy.
In rare cases of an INTERACT meeting resulting in changes to the initial advice provided, preliminary responses will be annotated and re-sent to you within 30 calendar days. In the case of a Written Response Only (WRO), the WRO will serve as meeting minutes from the FDA. [1]
If you’ve taken advantage of the INTERACT meeting, you may have gained some direction that helps your continued regulatory journey towards the Pre-IND meeting.
Center for Biologics Evaluation and Research (CBER) - The Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
Person or entity who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. Sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.
Written Response Only (WRO) refers to written responses sent in lieu of an in-person or virtual meeting, or a teleconference
Food and Drug Administration is a U.S. government agency responsible for regulating food, pharmaceuticals, cosmetics, and medical devices