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Dec 07, 2025
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PHSC 401 - Drug Regulatory Affairs
Credits: 2
Provides a general introductory overview of the key role that Regulatory Affairs plays in a pharmaceutical company’s launching of new drugs in the market. The laws, regulations, policies and procedures, and the FDA’s Standard operating procedures (SOP’s) that the FDA issues to drug companies to better understand FDA’s expectations.
Prerequisite(s): Junior/Senior Classification and instructor’s approval.
Offered: F, S.
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