“Through the first four months after the premarket tobacco applications (PMTA) deadline, the Food and Drug Administration (FDA) processed submissions from more than 230 companies. According to a post from Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP), as of mid-January, the agency completed the processing step of applications for more than 4.8 million products from those companies. After a company submits the application, the FDA begins processing the PMTA to properly receive and prepare it for review. The steps, as Zeller outlined, include physical or electronic intake of the submission and determining the type and number of applications contained in the submission. “One firm submitted information on more than 4 million tobacco products within a single submission. The amount of content in each submission also greatly varied, with some applications including up to 2,000,000 files where each file contains multiple pages of content for FDA to review,” he added. The agency continues to move through the processing steps of the PMTA submissions, and once complete, will release a list of products submitted under all three pathways for FDA approval: PMTA, Substantial Equivalence (SE) and Substantial Equivalence Requests (EX REQ).”
BILL TARLING — The FDA said that they have processed more than 4.8 Million PMTA submissions since September 2020 [i.e. over 5 months processing so far] just do do intake recording of the submissions — they haven’t even reached the Reviewing Stage], and they admit 1 company alone submitted for over 4 million products, and some applications have over 2 million files submitted. Rather turtle paced considering the FDA and Zeller originally said the PMTA would only affect a couple of hundred companies and products. So far the only products being approved are for tobacco company products.
ARTICLE LINK: FDA Processes Premarket Tobacco Applications for 4.8M Tobacco Products
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