Development framework, CDER-CBER Data Standards Strategy
The Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) released the data standards strategy for 2018-2022 on Monday. The purpose of the CBER-CDER Data Standards Strategy is to reinforce the ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the pre- and postmarket regulatory review process so that safe and effective medical products are available to patients.
Regulatory framework for the data standards strategy
The data standards strategy is supported by the U.S. Food and Drug Administration’s (FDA) current regulatory framework. FDA’s goal is to improve the predictability, consistency, transparency, and efficiency of the regulatory review process. Much of the improvement in the review process has hinged upon the submission of standardized electronic medical product application data and the implementation of electronic review tools and systems. The key areas of the current regulatory framework include:
- Requirements for Submissions of Labeling for Human Prescription Drugs and Biologics in Electronic format, 2003
- Food and Drug Administration Amendments Act (FDAAA), 2007
- Food and Drug Administration Safety and Innovation Act (FDASIA), 2012
- Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements, 2014
- 21st Century CUres Act, 2016
Strategic goals of the data standards strategy
CDER and CBER provide six goals for the 2018-2022 data standards strategy. The goals focus on key areas that will help improve the exchange, review, and management of medical product.
- Incorporate data standards to support more efficient, science-based pre-market review of medical products
- Improve the post-market risk management strategies and pharmacovigilance and surveillance of medical products by using data standards
- Implement common data standards to improve the quality and integrity of marketed medical products
- Promote innovation in the development and use of data standards
- Ensure effective communication and collaboration with stakeholders on data standards
- Improve the management and usability of the volume of information through data standards
Pearl Pathways routinely provides regulatory strategy and global filing support for startup to large multinational life science companies. Our team has broad expertise across the entire spectrum of regulatory requirements including clinical, non-clinical, CMC, Design Controls, 21 CFR Part 11, and the nuances of companion diagnostics. Learn about the types of filings we support and how we help clients with the eCTD format for regulatory submissions through FDA’s Electronic Submissions Gateway here.