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Cavellani CL, Gomes NC, de Melo e Silva AT, et al

While the data requirements needed for approval of a New Drug are substantial, applications can be filed under the procedure at Section 505 (b)(2) of the FDCA and rely on the vast data already in FDAs possession with regard to the existing NRT approvals

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& Elazar, Z

It also weakens the immune response, which means smokers with TB have worse outcomes compared to non-smokers