By Rebecca Mayo, J.D.
In a new draft guidance, the FDA proposed a program to facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition.
The FDA proposed a new program at the 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. The draft guidance titled "CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality," outlines the new program’s intended use of agency expertise to evaluate and informally recognize voluntary consensus standards that are potentially useful to industry and CDER staff. The program will also provide transparency to industry and other stakeholders regarding CDER’s thinking about a particular method or approach, and promote the visibility and use of standards applicable to its public health mission (Notice, 84 FR 4076, February 14, 2019).
Goals. FDA Commissioner Scott Gottlieb highlighted in a press release the new programs as an effort to promote development and appropriate use of consensus standards to help expedite pharmaceutical development and streamline the review of drug applications. The FDA’s hope is that providing a list of recognized standards on the FDA website, will provide transparency regarding FDA thinking on particular standards, which will help industry compile information for applications, and streamline the FDA’s assessment.
Evaluation. After CDER considers any public comments it receives in response to the issuance of thedraft guidance, the Pharmaceutical Quality Standards Working Group (PQSWG) will develop an internal process for informally recognizing standards in whole or in part, and document this process in a publicly available Manual of Policies and Procedures. The PQSWG will evaluate all requests for informal recognition of voluntary consensus standards and confirm that they are not in conflict with any statute, regulation, or policy under which FDA operates. It will confirm that they adhere to the basic elements of openness, balance, due process, appeals process, and consensus that are detailed in the draft guidance.
If it meets the PQSWG’s qualifying criteria, the PQSWG May recommend the formation of a subgroup of subject matter experts to review the standard or that an FDA laboratory evaluate the proposed standard. The subject matter experts will prepare an information sheet describing the scope and extent of CDER’s informal recognition of that standard and the PQSWG will review and approve the information sheet prior to publication. The CDER intends to list the voluntary consensus standard and publish the accompanying information sheet on a searchable database on CDER’s public website.
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