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Jul 04, 2025
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2023-2025 Catalog Volume XXXI Ver 1
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PSC 6019 Regulation of Pharmaceutical Products Lecture: 3 Lab: 0 Practica: 0 Total Credits: 3 This course provides a detailed review of the national and international regulatory requirements for the development, evaluation, and approval of pharmaceutical products. Topics include reviews of worldwide regulatory guidance documents, preparation of regulatory submissions including INDs and NDAs, protocols for formal interactions with regulatory agencies, and regulatory requirements for advertising and promoting of pharmaceutical products. In addition, the necessary requirements to ensure that all steps of a pharmaceutical development program remain compliant with all governmental rules and regulation are presented.
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