Draft Guidance – CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality

FDA is announcing the availability of a draft guidance for industry entitled CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.  This guidance describes a proposed program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality.  

This program, once established, will facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition.  This informal program will help streamline the compilation and assessment of marketing applications for products regulated by CDER.  The applicant’s use of an informally recognized consensus standard will be strictly voluntary.  CDER also believes that this program will: 

(1) allow CDER to communicate to external stakeholders that its relevant expert(s) have evaluated a consensus standard and determined if that standard is potentially useful both to industry and CDER staff and 

(2) provide transparency to industry regarding CDER’s thinking about a method or approach. 

CDER is issuing this draft guidance to obtain public comments on the proposed program.  We encourage interested parties to submit comments through the associated docket (FDA-2018-D-4417).    CDER will consider comments submitted to the docket when establishing the program and publishing a final guidance.  Once the guidance has been finalized, CDER will start accepting submissions to recognize voluntary consensus standards.