Sage Journals: Discover world-class research

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Research article

First published 1992-7

NDA Day Strategy and Success for ICI Pharmaceuticals Group's Diprivan® (PROPOFOL)

Gustavo Acosta, Nanette E. Holston

Therapeutic Innovation & Regulatory Science

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Research article

First published 1986-4

Postmarketing Reporting of Adverse Drug Reactions to the FDA: An Overview of the 1985 FDA Guideline

Judith M. Sills, Gerald A. Faich, Julie B. Milstien [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 1996-1

Evaluation of Preclinical Findings for 10-Day IND Safety Reports: FDA Considerations

Kenneth L. Hastings, James G. Farrelly, Alan Taylor

Therapeutic Innovation & Regulatory Science

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Research article

First published 1986-4

The Processing of Adverse Reaction Reports at FDA

Wayne M. Turner, Julie B. Milstien, Gerald A. Faich [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-11

An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic

Petra Dörr, Alison Wadworth, Tina Wang [...]

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 2008-3

Fluorescein Diacetate for Determination of Cell Viability in Tissue-Engineered Skin

Alexis D. Armour, Heather M. Powell, Steven T. Boyce

Tissue Engineering Part C: Methods

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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

Open access

Review article

First published 2010

Safety and Efficacy of Levonorgestrel 0.10 mg and Ethinyl Estradiol 0.02 mg plus Ethinyl Estradiol 0.01 mg in an Extended-Cycle Oral Contraceptive Regimen

Radhika Rible, Ram Parvataneni, Angela Chen

Clinical Medicine Insights: Therapeutics

Free access

Research article

First published 2012-1

17-α Hydroxyprogesterone Caproate for the Prevention of Preterm Birth

Simi Gupta, Ashley S Roman

Women's Health

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