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The New Age of Tobacco Product Application, Review Processes

Agility is helping the agency’s regulatory processes to expedite application submission and review.

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The Food and Drug Administration’s Center for Tobacco Products is leveraging emerging technologies to drive new efficiencies across its premarket review process, the center’s Office of Science Director Matt Holman said during an FDA meeting last week.

“These efforts include improving our information technology systems, engaging with stakeholders, significantly increasing our hiring, as well as streamlining our review processes,” Holman said.

In the summer of 2019, courts ordered pre-market applications for newer tobacco products like e-cigarettes, pipes, hookahs and certain types of cigars to be submitted to the agency by Sept. 9, 2020. Products that were submitted by the deadline could remain on the market for up to a year while pending FDA review.

“By implementing the premarket review process for all deemed new tobacco products, we are taking steps to transform the marketplace,” said Holman, whose office is charged with providing CTP with scientific support for regulations and also reviews its tobacco applications. “This undertaking represents a major milestone for tobacco product regulation and for public health as a whole.”

To prepare for FDA’s Sept 9, 2021, deadline to review these submissions, CTP began transforming its workforce, going from 40 employees in 2011 to 500 now, Holman said.

The office also leveraged a multi-faceted approach to its IT systems to make electronic applications more accessible and allow applicants to group submissions.

“I’m very happy to report today that a lot of manufacturers did, in fact, submit electronically,” Holman said. “As a result of all of that preparation, we were successful in receiving over 6.5 million applications within a window of just a few weeks.”

To support these group submissions, FDA developed a new tool — the cloud-based Product Data Service. The tool houses submission product data, which is then used to generate lists of submissions and products received from industry. That tool also helps FDA efficiently determine and report on products under review.

The system and workflow can also lead to enhanced data-sharing capabilities and making certain data public, noted Crystal Allard, director of the office’s Division of Regulatory Science and Informatics (DRSI).

As CTP continues to review submissions, Allard noted that there was a large emphasis on consistency to overcome challenges while scaling up.

“We paired staff working on the process with staff working on building IT systems and building new databases to ensure we could consistently provide the same types of information to the reviewers during a consistent process, so that our reviewers were able to understand what was expected of them and could work a very consistent process,” Allard said.

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