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We also gathered specifics of notices of FDA regulatory steps accessible on the Federal Register22 plus the therapeutic course with the WHO Anatomical Therapeutic Chemical Classification System23 (Supplemental Desk S1). We classified the medication using the anatomical primary group. We selected the therapeutic subgroup for systemic anti-infectives
(a) All details submitted below this component must be transmitted to FDA electronically in accordance with § 207.61(a) Except if FDA has granted a request for waiver of the need prior to the date on which submission of these information and facts is owing. Submission of the ask for for waiver does not excuse timely compliance With all the registr
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