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Restricted accessResearch articleFirst published November, 2016

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

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

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published July, 2013

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

Restricted accessOtherFirst published July, 2005

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

Restricted accessOtherFirst published July, 1993

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

Nancy D. Smith

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published October, 1993

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

James H. Lewis

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published September, 2016

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

Partha Pratim Basu

India Quarterly: A Journal of International Affairs

Restricted accessResearch articleFirst published November, 2003

Aripiprazole: An Antipsychotic with a Novel Mechanism of Action

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

Journal of Pharmacy Technology

Search results

Articles (7)

Journals (0)

1-7 of 7 results for NDA comparison

Sort by:

Relevance

Select all

Sort by:

Relevance

Restricted accessResearch articleFirst published November, 2016

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

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

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published July, 2013

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

Restricted accessOtherFirst published July, 2005

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

Restricted accessOtherFirst published July, 1993

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

Nancy D. Smith

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published October, 1993

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

James H. Lewis

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published September, 2016

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

Partha Pratim Basu

India Quarterly: A Journal of International Affairs

Restricted accessResearch articleFirst published November, 2003

Aripiprazole: An Antipsychotic with a Novel Mechanism of Action

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

Journal of Pharmacy Technology