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Research article

First published 1990-7

FDA Perspective on Computer Assisted Pharmacology/Toxicology Review

Michael R. Hamrell

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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Review article

First published 2018-9

Implementation of Question-based Review in support of Quality by Design streamlining the US FDA’s review process

Alisha Desai, Jayanta Kumar Maji, Kanhoba Walavalkar [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Other

First published 1999-4

Individual Bioequivalence—A Review of the FDA Draft Guidance

Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

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Other

First published 1995-4

Interim Analyses: An FDA Reviewer's Experience and Perspective *

A. J. Sankoh

Therapeutic Innovation & Regulatory Science

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Other

First published 1999-1

Interim Analyses: An Update of an FDA Reviewer's Experience and Perspective *

A. J. Sankoh

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-9

Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review

Samuel A. Bonet, Farzan Sasangohar, Mark Lawley

Proceedings of the Human Factors and Ergonomics Society Annual Meeting

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Research article

First published 1987-4

FDA'S Conduct,Review,and Evaluation of Inspections of Clinical Investigators

Gurston Turner, Alan B. Lisook, Dana P. Delman

Therapeutic Innovation & Regulatory Science

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Research article

First published 2007-9

How to Improve Complex Drug Development? A Critical Review of FDA Advisory Meetings

Pol F. Boudes

Therapeutic Innovation & Regulatory Science

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Other

First published 1993-7

Quality of Life Studies from the Perspective of an FDA Reviewing Statistician *

Nancy D. Smith

Therapeutic Innovation & Regulatory Science

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