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FDA issues final guidance on using remote oversight tools to help approve drugs FDA has issued a final guidance on how the agency intends to use alternative tools in advance, in lieu of, or in support of preapproval and prelicense inspections to remotely evaluate drug manufacturing facilities named in pending applications as part of FDAs drug

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Similarly, a trial in 117 participants did not find evidence that the addition of nicotine patch to varenicline increased abstinence at 1, 4, or 12 weeks after the targeted quit date, and no between-group differences in adverse effects were found