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- Title
Lawsuits anticipated on generic biologicals front.
- Authors
Fox, Jeffrey L.
- Abstract
Reports that the U.S.-based Biotechnology Industry Organization (BIO) submitted a citizen's petition to the U.S. Food and Drug Administration (FDA), requesting an open public discussion of agency policy regarding therapeutic proteins and other biotechnology products. Description of the dispute between the U.S.-based pharmaceutical company Pfizer Inc. and India-based Dr. Reddy's Laboratories Ltd.; Opinion of BIO regarding drug approval given by FDA.
- Subjects
UNITED States; HEALTH policy; UNITED States. Food &; Drug Administration; DRUG approval; PFIZER Inc.; DR. Reddy's Laboratories Ltd.
- Publication
Nature Biotechnology, 2003, Vol 21, Issue 7, p721
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0703-721