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Transparency practices at the FDA: A barrier to global health
Murray M Lumpkin1, Margaret A Hamburg2, William B Schultz3
1Bill & Melinda Gates Foundation, Seattle, WA, USA.
Science (New York, N.Y.)
|August 4, 2022
Summary
Regulatory data sharing should become standard practice. This ensures efficient collaboration and timely decision-making in regulatory processes, making it routine rather than exceptional.
Area of Science:
- Regulatory Science
- Information Management
Background:
- Current data sharing practices among regulatory bodies are often inconsistent.
- Establishing routine data sharing is crucial for modern regulatory oversight.
Purpose of the Study:
- To advocate for the normalization of data sharing among regulatory agencies.
- To highlight the benefits of integrated data exchange for regulatory functions.
Main Methods:
- Analysis of current regulatory data sharing protocols.
- Review of best practices in inter-agency information exchange.
Main Results:
- Data sharing is essential for efficient regulatory operations.
- Treating data sharing as 'business as usual' streamlines processes.
Conclusions:
- Regulatory data sharing must be standardized.
- Implementing routine data sharing enhances regulatory effectiveness and compliance.
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