CBER Draft Guidance on Standards Development and the Use of Standards in Regulatory Submissions 

On Tuesday, December 19, 2017, the FDA Center for Biologics Evaluation and Research (CBER) issued the draft guidance for public review and comment: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff.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 The SCB encourages stakeholders to submit comments to the draft guidance before the FDA begins work on the final version of the guidance.  The SCB will facilitate discussions among its members related to the content of the draft guidance and potential for providing comments.

FDA Sterility Regulation 21 CFR 610.12

In 2012, the FDA amended the sterility test requirements for biological products.  This rule provided manufacturers of biological products greater flexibility, as appropriate, and encouraged the use of the most appropriate and state-of-the-art testing methods for assuring the safety of biological products.  Click here for a link to the Federal Register (FR) publication and explanation of the regulation change.

The current sterility regulation, as published in the Code of Federal Regulations (CFR), Title 21 can be found here.