Association for Accessible Medicines filed 1 comment on this docket between Nov 23, 2022 and Nov 23, 2022. 15 other organizations filed here. The comment window closed 1341d ago.
FDA, Please find attached comments from the Association for Accessible Medicines regarding Proposed Rule: "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (Docket Number FDA-2021-N-0862). Scott Kuzner, Senior Director, Sciences & Regulatory Affairs at the Association for Accessible Medicines.
The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.
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