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REGULATORY PRACTICE AND COMPLIANCE

ABT 740
Course Description

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.

Prerequisties
Satisfies

This course does not satisfy any prerequisites.

Credits

3

Offered

Not Applicable

Grade Point Average
3.93

0.09% from Historical

Completion Rate
100%

No change from Historical

A Rate
85.71%

0.84% from Historical

Class Size
7

40% from Historical

Instructors (2025 Fall)

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