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Modernizing FDA’s Data Strategy: Agency Announces March 27 Public Meeting, Requests Written Comments by End of April

On January 7, 2020, the US Food and Drug Administration (FDA) announced that it will hold a public meeting on March 27 to discuss possible Agency-level approaches to modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange and data analytics. Topics for discussion during the public meeting—and in written comments submitted to the parallel public docket—include the following:

Standards and policy, including:

  • How can FDA best use policy and common data standards to help ensure the effective and efficient use of data assets?

  • What are the consequences/issues as we move from ”static point-in-time data sets” to updating digital data streams for analyses?

  • As we move into increased sharing and integrated data sets, how might FDA manage data in a way that avoids unnecessary duplication?

Data security, privacy and management including:

  • How can FDA modernize its data strategy to continue ensuring privacy and security of data?

  • What should FDA do to promote the management and organization of data assets across the Agency, as the amount and complexity of data (e.g., in regulatory submissions to FDA) is rapidly increasing?

Data strategies and data sharing, including:

  • How can FDA’s data strategy facilitate broader goals of integration and interoperability of healthcare data, and scientific data/virtual patient data generated using scientific models?

  • How can FDA design its data strategy to reflect a global marketplace and promote clarity to data providers like regulated industry and other stakeholders?

  • How can FDA design its data strategy and policy development to facilitate appropriate data access, data sharing within the Agency and via data sharing agreements, as well as the appropriate reuse and repurposing of data to advance Agency regulatory science priorities?

  • For stakeholders, including regulated industry, that submit data to FDA, how can FDA enhance the efficiency of the preparation and submission of data to FDA?

Individuals interested in presenting at and/or participating in a panel at the meeting should apply to do so by providing the information described in the Federal Register by January 28, 2020. Stakeholders who only wish to attend the public meeting in person must register by March 24, 2020. Lastly, stakeholders who intend to provide written feedback on this topic should submit written comments to the public docket by April 30, 2020.

Implications

The public meeting and docket represent the agency’s latest effort to deal with the rapid, ongoing uptick in the amount and complexity of data that increasingly informs regulatory decision-making. Interested stakeholders should take advantage of this opportunity to provide the agency with meaningful input on how best to update its existing data strategy.

© 2020 McDermott Will & Emery

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About this Author

Michael Ryan Attorney specializing in Pharma law McDermott Law Firm
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Michael W. Ryan is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.

Michael focuses his practice on the legal, regulatory and reimbursement issues that manufacturers and investors encounter in the development and commercialization of pharmaceuticals, medical devices, biotechnology products and laboratory services.  Michael counsels entities as they seek to obtain authorization to market their products from the U.S. Food and Drug Administration, maintain compliance with applicable laws and regulations (including the...

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Vernessa Pollard Pharmaceutical Attorney McDermott
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    Vernessa T. Pollard is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C., office. Vernessa serves as co-head of the Firm’s Food and Drug Administration (FDA) practice.

    Vernessa advises companies on regulatory, compliance, enforcement and legislative matters involving pharmaceuticals, medical devices, digital and mobile health, health IT solutions and services, and emerging technologies and software. She also advises national and international food and cosmetic producers and retailers on regulatory and compliance issues related to food and cosmetic marketing and safety.

    Vernessa regularly counsels companies on product approvals and premarket strategy, Good Manufacturing Practice (GMP) and Quality System (QS) requirements, advertising and promotion, adverse event reporting, FDA Warning Letters, FDA inspections, recalls, import detentions and corporate compliance programs. She has represented companies and executives in FDA and Department of Justice (DOJ) investigations and enforcement matters. She also conducts due diligence evaluations and analyses of FDA regulatory issues relating to mergers and acquisitions.

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