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# Comments on FDA Data Strategy
- URL: https://www.fdaweb.com/comments-on-fda-data-strategy/
- Published: 2020-04-30T12:00:00.000Z
- Updated: 2026-09-14T16:13:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146687

A task force from BioPhorum and the Pharmaceutical Process Analytical Round Table tells FDA the pharmaceutical and biopharmaceutical industries are facing challenges and uncertainties with regards to regulatory expectations for the validation, registration, and lifecycle management of multi-variate data analysis (MVDA) models used in process analytical technology and real-time release testing applications. “The industry is therefore looking for a standardized path forward to the validation, registration, and lifecycle management of MVDA models,” the task force says in its [comment letter](https://www.regulations.gov/document?D=FDA-2019-N-5799-0004&ref=fdaweb.com) in response to an FDA docket on modernizing FDA’s data.

RareX, which works with rare disease patient communities, [says](https://www.regulations.gov/document?D=FDA-2019-N-5799-0005&ref=fdaweb.com) that currently in rare disease research and care critical data are often **(1)** not available due to lack of access to genomic testing or patient records and histories; **(2)** not always consented, developed, structured, or organized or maintained properly, or **(3)** siloed and restricted as a result of academic and commercial disincentives, concerns about sharing of data, lack of cooperation or trust among stakeholders, regulatory and policy barriers, etc. The organization says that rethinking the approach to data collection, access, and sharing will result in enhanced research productivity at scale, more efficient drug development, federated research-ready data, increased ability to support patient-owned research-ready data, and support for sustained, meaningful, targeted patient/community engagement.

In its [response](https://www.regulations.gov/document?D=FDA-2019-N-5799-0006&ref=fdaweb.com), the Confidentiality Coalition says it “strongly supports an innovative healthcare system that harnesses data to elevate the quality of care delivery, turbocharges medical research, and enables greater efficiencies within the system.” The coalition recommends that FDA address data stewardship and modernizing its data strategy through the lens of the coalition’s “Beyond HIPPA Privacy Principles” document.