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Study settings and participants Initially, a series of meetings among the investigators of two government institutes of national excellence of India (referred to as Institute 1 and Institute 2, respectively henceforth) along with the representatives from funding partners viz

8 (2025): 134554, US Food and Drug Administration, Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products, August 26, 2025, The FDA does not report how many products have live PMTAs under review, though it could do so at the aggregate level without disclosing commercially sensitive information

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