On Tuesday, December 19, 2017, the FDA Center for Biologics Evaluation and Research (CBER) issued the draft guidance for public review and comment: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff. This guidance document describes what standards are and how they are developed by Standards Development Organizations (SDOs). The guidance document also addresses questions on how sponsors can use standards to facilitate product development and regulatory submissions, and acceptance of such use of standards by the FDA.
The comment period for the guidance is open until March 19, 2018. The SCB encourages stakeholders to submit comments to the draft guidance before the FDA begins work on the final version of the guidance. The SCB will facilitate discussions among its members related to the content of the draft guidance and potential for providing comments.