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NPA Proposes Streamlined Data Sharing at FDA

Colorcon
 
Kaneka

The Natural Products Association (NPA) outlined a streamlined process to facilitate data sharing within the agency in comments to the U.S. Food and Drug Administration (FDA). Specifically, NPA suggested sharing data from the Office of Dietary Supplement Programs on structure/function claim notifications, new dietary ingredient (NDI) notifications, current good manufacturing practice (cGMP) inspections and certificate of free sale applications.

Non-GMO Project

“Providing more information to the general public will allow responsible supplement manufacturers and retailers to better work with the agency. NPA is committed to working with the FDA to ensure that our members have access to the information necessary to provide safe, reliable products to consumers,” said Daniel Fabricant, PhD, president and CEO of NPA.

NPA outlined a process for database design and data sharing: “FDA should design its data strategy and policy development to facilitate communication and awareness of shared issues between offices, especially those offices that are located within the same center. Offices within the same center should have a mechanism for informing them of the existence of data or information that could impact, or overlaps, with their commodity. This could be achieved through the use of a central database, like an enterprise system that shared data and information across each center and possibly across the agency. This type of system would provide offices with a means for searching across the center’s data (rather than just search within their own office’s files and/or data) to determine if there is any overlap that would necessitate data sharing. Once overlapping areas were identified, the offices could request access to the data to ensure that their review was fully comprehensive.”

For more information, visit www.npanational.org.

Kaneka
 
Colorcon