FDA revises MAPPs on data standards program, scientific interest groups

Regulatory NewsRegulatory News | 01 September 2021 |  By 

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) recently issued two revised documents for its Manual of Policies and Procedures (MAPP): one addresses updated procedures for its data standards program and the other covers operational procedures for scientific interest groups (SIG).
The 10-page MAPP on data standards governance discusses the operating model to support the implementation of CDER’s data standards program. It revises a former version issued in September 2015 by including the new Business Informatics Governance (BIG) council, set up to govern process, data, technology and business informatics activities.
The revised MAPP also updates the name of the Data Standard Governance Board  to the Data Standards Program Board the; the board’s responsibilities remain the same. This body is charged with providing leadership and strategic oversight to CDER data standards and data governance programs.
“The US Food and Drug Administration (FDA) receives a vast and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. These data hold great potential to advance CDER’s regulatory and scientific work, however, the present lack of standardized data creates significant challenges to conducting thorough and well-organized reviews,” states the MAPP.
CDER established the data standards program in 2010 to help meet its performance goals under the Prescription Drug User Fee Act (PDUFA) 5. Each year, CDER receives more than 150,000 submissions, translating into “millions” of pieces of data, which can arrive in a “wide variety of formats and even on paper, complicating the review process,” according to FDA’s website. The program aims to simply the process by requiring that submissions meet certain data standards.
This MAPP is tied into CDER and the Center for Biologics Evaluation and Research (CBER)’s shared strategy for selecting, developing and implementing data standards over the next five years. (RELATED: CDER, CBER Outline Data Standards Strategy Through 2022, Regulatory Focus, 5 February 2018)
The MAPP went into effect on 31 August.
MAPP addresses policies for scientific interest groups
Another MAPP outlines the policies governing the operation of Scientific Interest Group (SIGs) in the CDER’s Office of Clinical Pharmacology (OCP). SIGs are meant to “support professional development based on personal scientific interests, develop increased scientific expertise within OCP, and provide opportunities for mentorship within OCP.”
The MAPP remains substantially the same as the former MAPP issued in 2009. FDA has made such minor revisions as deleting a provision that each SIG have a minimum of three members, as well as aprovision stating that additional members may join the SIG at any time with their supervisor’s concurrence.
The MAPP went into effect on 1 September.
FDA MAPP on data standards governance
FDA MAPP on scientific interest group
FDA’s data standards program


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