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- Title
FOLLOW-ON BIOLOGICS, DATA EXCLUSIVITY, AND THE FDA.
- Authors
Linfong Tzeng
- Abstract
The article provides information on the efforts of the U.S. Congress to create an incentive structure in the biotechnology industry that will increase competition and reduce the costs of protein based therapeutic drugs known as biologics. It informs that because of high cost of biologics, Congress is exploring legislation for the development of Follow-on Biologics (FOB). It further informs that the U.S. Food and Drug Administration (FDA) will set the bar for clinical trials.
- Subjects
UNITED States; BIOLOGICALS; LABOR incentives; UNITED States. Congress; UNITED States. Food &; Drug Administration; BIOTECHNOLOGY industries
- Publication
Berkeley Technology Law Journal, 2010, Vol 25, Issue 1, p135
- ISSN
1086-3818
- Publication type
Article