FDA is announcing the expansion of the CDER NextGen Portal to enable certain electronic submissions to FDA under section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (over-the-counter (OTC) monograph submissions).
FDA is announcing the expansion of the CDER NextGen Portal to enable certain electronic submissions to FDA under section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (over-the-counter (OTC) monograph submissions).
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