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Articles (12)

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1-10 of 12 results for Food and Drug Administration Modernization Act of 1997

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Select article: The Single Controlled Trial: Industry Survey Indicates That Implementation is Still a Work in Progress

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First published 2002-4

The Single Controlled Trial: Industry Survey Indicates That Implementation is Still a Work in Progress

Christopher-Paul Milne

Therapeutic Innovation & Regulatory Science

Select article: Measuring the Pace of New Drug Development in the User Fee ERA

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First published 2000-7

Measuring the Pace of New Drug Development in the User Fee ERA

Kenneth I. Kaitin, Joseph A. DiMasi

Therapeutic Innovation & Regulatory Science

Select article: The New Drug Approvals of 1996,1997,and 1998: Drug Development Trends in the User Fee Era *

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First published 2000-1

The New Drug Approvals of 1996,1997,and 1998: Drug Development Trends in the User Fee Era *

Kenneth I. Kaitin, Elaine M. Healy

Therapeutic Innovation & Regulatory Science

Select article: The New Drug Approvals of 1999,2000,and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

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First published 2003-10

The New Drug Approvals of 1999,2000,and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

Kenneth I. Kaitin, Catherine Cairns

Therapeutic Innovation & Regulatory Science

Select article: The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

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First published 2001-1

The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

Janice M. Reichert, Jennifer Chee, Claire S. Kotzampaltiris

Therapeutic Innovation & Regulatory Science

Select article: The Food and Drug Administration Modernization ACT and the Food and Drug Administration: Metamorphosis or Makeover?

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First published 2000-7

The Food and Drug Administration Modernization ACT and the Food and Drug Administration: Metamorphosis or Makeover?

Christopher-Paul Milne

Therapeutic Innovation & Regulatory Science

Select article: The Food and Drug Administration'S Fast Track Designation: Observations from the Initial Two Years of this Designation

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First published 2000-7

The Food and Drug Administration'S Fast Track Designation: Observations from the Initial Two Years of this Designation

David M. Cocchetto

Therapeutic Innovation & Regulatory Science

Select article: Pediatric Exclusivity

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Review article

First published 2014-3

Pediatric Exclusivity

Donna R. Rivera, Abraham G. Hartzema

Annals of Pharmacotherapy

Select article: Centers for Education and Research on Therapeutics (CERTs) *

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First published 2002-7

Centers for Education and Research on Therapeutics (CERTs) *

Judith M. Kramer, Lynn A. Bosco, Robert M. Califf

Therapeutic Innovation & Regulatory Science

Select article: New Pathways for Evaluating Potential Acute Stroke Therapies

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Research article

First published 2006-5

New Pathways for Evaluating Potential Acute Stroke Therapies

Marc Fisher, Kenneth Cheung, George Howard [...]

International Journal of Stroke

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