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Apr 15, 2026
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BIOTEC 560 - Introduction to Regulatory Affairs
Prerequisites: BS in a STEM field, Certificate in Biotechnology.
Requirement Fulfillment: Fulfills a 3-credit course for the 4+1 MA in Biotechnology
Delivery: Lecture
This course provides an introduction to the regulatory requirements to obtain and maintain market authorization for medical products in the United States, according to the statutes issued by the United States Congress, the Code of Federal Regulations, and subsequent Rules, Guidance, and common practices. The structure and responsibilities of the US Food and Drug Administration and its various Centers, Offices, Divisions, and Branches will be outlined. The basic regulatory requirements for the development, preclinical testing and clinical trials, product submission and review, market authorization process, and post-marketing requirements are the key focus areas of this course. Medical devices, pharmaceutical products (both small molecule and macromolecule- biologics), and diagnostic products are included.
3 credits
Fall
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