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3. US Congress. Food and Drug Administration Amendments Act of 2007 Pub L No. 110-85, 121 Stat 823. http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf.
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5. Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed;Nicholson;Expert Opin Drug Saf,2012