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2. Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Direct final rule. Food and Drug Administration, HHS. Fed Regist; 2008 Sep 29; 73(189):56487-91. PubMed ID: 18985960 [Abstract] [Full Text] [Related]
3. Drug safety reform at the FDA--pendulum swing or systematic improvement? McClellan M. N Engl J Med; 2007 Apr 26; 356(17):1700-2. PubMed ID: 17435081 [No Abstract] [Full Text] [Related]
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5. Biogenerics standoff. Herrera S. Nat Biotechnol; 2004 Nov 17; 22(11):1343-6. PubMed ID: 15529145 [No Abstract] [Full Text] [Related]
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15. Ensuring the safety of genotech drugs through implied warranty theory. Serra WM. Am J Law Med; 1997 Oct 18; 23(2-3):363-81. PubMed ID: 9262761 [No Abstract] [Full Text] [Related]
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