date:Jul 17, 2015
continue to engage in discussions with the covered businesses and to answer questions about how the rule applies in particular situations. In addition, the FDA plans to issue in August 2015 a draft guidance document that provides answers to some of the more frequently asked and crosscutting questions that the agency has received to further assist covered establishments in complying with the rule. There will be an opportunity for comment on the draft.
In addition to the guidance, the FDA will a