New Drug Development: A Regulatory Overview

RGA 6201 4 Quarter Hours
Course Level CPS - Graduate
Description Examines every step of the drug development and regulation process, from preclinical testing through postmarketing adverse experience reporting. Considers FDA standards for nonclinical testing-quality assurance issues and good laboratory practice, investigational new drug application (NDA) and review process initiatives designed to speed drug review, and the Prescription Drug User Fee Act (PDUFA).

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

Section 01
CRN 20118
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Schedule Wednesday, 5:50 pm - 7:30 pm
Campus Boston Main Campus
Course Format Blended
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 20131
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Lori Fiorentino
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
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