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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

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Research article

First published 2012-10

Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators

M. E. Blair Holbein, Jelena Petrovic Berglund

Journal of Investigative Medicine

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Research article

First published 2009-8

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

M. E. Blair Holbein

Journal of Investigative Medicine

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Research article

First published 2013-1

How FDA Advisory Committee Members Prepare and What Influences Them

Todd D. McIntyre, Mimi Pappas, James J. DiBiasi

Therapeutic Innovation & Regulatory Science

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First published 2000-1

Preparing for FDA Advisory Committee Presentations: Perspective of an Advisory Committee Member *

Richard L. Schilsky

Therapeutic Innovation & Regulatory Science

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First published 2011-5

Substantial Evidence: When is a Single Trial Sufficient for Approval and Promotion?

David Coutant, David Riggs, Elizabeth Van Sant Hoffman

Therapeutic Innovation & Regulatory Science

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Other

First published 2008-7

Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors

Mary Vanderhoof, Michael J. Umen, David N. Schwartz

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-11

An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research

Khushboo Sharma, Afi Harrington, Sallamar Worrell [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-1

FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

Nehar Damle, Shilvi Shah, Praneeta Nagraj [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 1992-6

Overview of the Food and Drug Administration Procedures for Expediting the Development and Evaluation of Drugs for the Treatment of Acquired Immunodeficiency Syndrome and Other Life-Threatening Illnesses

James R. Hunter, David L. Rosen, Robert DeChristoforo

Journal of Pharmacy Practice

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