Drugs

Comments on FDA Data Strategy Modernization

The Biotechnology Innovation Organization (BIO) says it supports FDA efforts to modernize its data strategy to ultimately transform the way data is shared, analyzed, and used for regulatory purposes. Commenting in advance of an agency public meeting on the topic, BIO says it will be important to remember that just as it will take FDA time to implement appropriate IT infrastructure and capabilities to ensure the modernization, the industry will need time to implement compatible technologies and processes as well.

The BIO letter asks that the agency consider these features as it continues to consider data modernization: transparency on the agency data strategy and inclusion of sponsors in discussions, expertise to support FDA’s data strategy, cross-Center, cross-government alignment and interoperability, international harmonization and interoperability, and collection of data through clinical trials.

In its comment, Pharmaceutical Research and Manufacturers of America says it strongly supports an agency-wide strategic data and technology approach that is transparent and promotes active collaboration with industry stakeholders to successfully ensure that necessary technology and innovation investments promote convergence in data compatibility, interoperability, and interpretability for current and future FDA data initiatives throughout the regulatory lifecycle. The trade association also underscores the need for a cross-Center approach to FDA’s digital and data strategy to help ensure that the appropriate infrastructure, processes, and tools are available to FDA staff and appropriately integrated into new reorganization business processes to promote effective drug and digital health product development and support consistent regulatory decision-making.

In its letter, Flatiron Health says it supports the agency’s strategic approach to data given the increasing availability and complexity of novel data sources underpinning regulatory decisions and broader HHS efforts to increase healthcare data interoperability.

Janssen says it believes that the development of an agency-wide strategic approach to modernizing FDA’s data strategy will benefit the entire healthcare ecosystem. The company makes suggestions and references two specific efforts it believes FDA could engage with and support—a cross-industry initiative called the Digital Endpoints Ecosystem and Protocol that wants to accelerate the adoption and standardization of digital measures to support regulatory submissions in clinical research and development, and Project Accumulus, a cross-industry initiative intended to transform communication and data exchange between industry and health authorities.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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