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Federal Food Drug Cosmetic Act [21 USC §355] SEC. 505(j). Abbreviated New Drug Applications (ANDA)
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Bioavailability and Bioequivalence Requirements; Abbreviated Applications; Final Rule
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A ssessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. Statement of Janet Woodcock, M.D., Deputy Commissioner, Chief Medical Officer, Food and Drug Administration before the Subcommittee on Health, House Committee on Energy and Commerce 2 May
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Patient Protection and Affordable Care Act (PPACA ). Title VII: Improving Access to Innovative Medical Therapies. Subtitle A: Biologic Price Competition and Innovation (BPCIA) provisions of the Patient Protection and Affordable Care Act (PPACA )-exclusivity provisions
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Patient Protection and Affordable Care Act (PPACA ). Title VII: Improving Access to Innovative Medical Therapies. Subtitle A: Biologic Price Competition and Innovation (BPCIA) provisions of the Patient Protection and Affordable Care Act (PPACA )-exclusivity provisions 〈http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/UCM216146.pdf
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Docket number FDA-2010-N-0477 FDA Public Meeting November 2010 Docket Link Federal Register Notice 5 October 10. Public submissions: 〈http://www.regulations.gov/#!searchResults;rpp=10;po=0;s= FDA-2010-N-0477〉.
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FDA Biosimilars User Fee Federal Register Notice Docket number FDA-2011-N-0326; Public Submissions: 〈http://www.regulations.gov/#!search Results;rpp=10;po=0;s=FDA-2011-N-0326
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