Deeming: Still Time to Comment
From: CSPnet.com
By Melissa Vonder Haar, Tobacco Editor
WASHINGTON — Andrew Perraut has a unique view on the U.S. Food and Drug Administration’s (FDA) rulemaking process, especially when it comes to deeming: asa policy analyst for the White House Office of Information and Regulatory Affairs (OIRA), Perraut was the lead for all regulatory issues for tobacco for six years (pre-dating the FDA’s Center for Tobacco Products) and participated in the redrafting of the deeming regulations before the proposed regs went public in April 2014.
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“The reality is, the process that the FDA has proposed is not very well fleshed-out,” he said. “They have not published the specific standards that they’re expecting applicants to meet, so a lot of this remains a little bit unknowable.”
