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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 2013-07

Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009

Rita Poon, Keshav Khanijow, Sphoorti Umarjee [...]

Journal of Women's Health

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Other

First published 2005-7

The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

Shunsuke Ono, Chisato Yoshioka, Orie Asaka [...]

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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Other

First published 1993-10

Risk/Benefit Assessment of New Drugs: Perspectives of a Former FDA Advisory Committee Member

James H. Lewis

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-9

Federalism and Foreign Policy in India—Experiences of UPA and NDA-II Regimes

Partha Pratim Basu

India Quarterly: A Journal of International Affairs

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Research article

First published 2003-11

Aripiprazole: An Antipsychotic with a Novel Mechanism of Action

Amy A Lemieux, Jennifer D Goldman-Levine, Jessica L Goren

Journal of Pharmacy Technology

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

Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009

The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

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

Risk/Benefit Assessment of New Drugs: Perspectives of a Former FDA Advisory Committee Member

Federalism and Foreign Policy in India—Experiences of UPA and NDA-II Regimes

Aripiprazole: An Antipsychotic with a Novel Mechanism of Action