LAW 576A - Drug Discovery, Development & Innovation to Reach the Marketplace
August 23 - October 13 • Fall 2021
Section 101/201 • 3 units • Graded • Online
This course navigates the drug development path stretching across the pre-clinical and post-marketing divide from the full range of drug regulation, including drug discovery, innovative drug development tools, and the post-approval phase. Intellectual Property protection and evaluation will be covered, along with FDA-enforced market exclusivity and FDA-expedited review programs. The course concludes with international regulatory perspectives, including the European Medicines Agency, the costs involved to bring drugs through the clinical trials to market in the US and abroad, and how this affects future investment and strategy.