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Articles (13)

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1-10 of 13 results for FDAMA

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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: 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: Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience

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First published 2001-1

Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience

Christopher-Paul Milne, Elaine Bergman

Therapeutic Innovation & Regulatory Science

Select article: Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split

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Research article

First published 2010-3

Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split

Jesse M. Boodoo

American Journal of Law & Medicine

Select article: Report of a Workshop on Confirmatory Evidence to Support a Single Clinical Trial as a Basis for New Drug Approval *

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First published 2002-7

Report of a Workshop on Confirmatory Evidence to Support a Single Clinical Trial as a Basis for New Drug Approval *

Carl C. Peck, Jill Wechsler

Therapeutic Innovation & Regulatory Science

Select article: Single-Study Approvals: Quantum of Evidence Required

Open access

Research article

First published 2019

Single-Study Approvals: Quantum of Evidence Required

Frank J. Sasinowski, Michelle L. Butler

Therapeutic Innovation & Regulatory Science

Select article: The Emergence and Growth of Clinical Trial Information Transparency

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First published 2010-5

The Emergence and Growth of Clinical Trial Information Transparency

Pamela A. Rose

Therapeutic Innovation & Regulatory Science

Select article: Clinical Trial Design and Alterations in Drug Disposition with Age *

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First published 2000-1

Clinical Trial Design and Alterations in Drug Disposition with Age *

Michael L. Christensen, Russell W. Chesney, Richard A. Helms

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

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