Beginning Tuesday, interested parties and members of the public will have 60 days to consider the proposal submitted to FDA in January of last year. The recommendations relate to manufacturing practices and the industry’s interpretation of existing regulations, according to a notice to be published in the federal register.
A docket will be created for comments and related materials, including the proposal, here.
In May, representatives of the companies met with FDA to make their case for the recommendations and how they would be developed. FDA has not made proposals public.