1 |
R. J. Strongin, Hatch-Waxman, generics, and patents: balancing prescription drug innovation, competition, and affordability, National Health Policy Forum (2002)
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2 |
W. H. Schacht and J. R. Thomas, The Hatch-Waxman act: legislative changes in the 108th congress affecting pharmaceutical patents, Congressional Research Service (2004)
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3 |
21 CFR 314.53, Submission of patent information
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4 |
J. R. Thomas, Authorized generic pharmaceuticals: effects on innovation. Congressional Research Service (2006)
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5 |
Library of Parliament in Canada, The patented medicines (notice of compliance) regulations 2006 (2007)
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6 |
Office of Patented Medicines and Liaison, Therapeutic products directorate statistical report (2006)
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7 |
Health Canada, Therapeutic products directorate statistical report (2007)
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8 |
Canada Patent Act, Regulations amending the patented medicines (notice of compliance) regulations (2006)
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9 |
C. McCourt, E. McMahon and I. VanderElst, Amendments to the patented medicines (notice of compliance) regulations and the data protection regulations are now in force, Torys LLP, October 10 (2006)
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10 |
US FDA, Guidance for industry: listed drugs, 30-month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drugs, Improvement and Modernization Act of 2003 (2004)
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11 |
21 CFR 314.95, Notice of certification of invalidity or noninfringement of a patent
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12 |
FTC, Generic drug entry prior to patent expiration (2002)
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13 |
R. G. Frank and E. Seiguer, Generic drug competition in the US. Business Briefing, Pharmatech (2003)
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