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Research article

First published 2012-5

The rosiglitazone decision process at FDA and EMA. What should we learn?

Koen B. Pouwels, Kees van Grootheest

International Journal of Risk & Safety in Medicine

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Research article

First published 2018-9

Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making:

Carrie M. Kuehn

Therapeutic Innovation & Regulatory Science

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Research article

First published 1995-10

The Evolution of FDA Policy on Silicone Breast Implants: A Case Study of Politics,Bureaucracy,and Business in the Process of Decision-Making

Howard A. Palley

International Journal of Social Determinants of Health and Health Services

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Research article

First published 2006-7

Teva v FDA and Apotex v FDA : Two Court Decisions on the Interpretation of a ‘Court Decision’

Frederick H. Rein, Amanda M. Kessel

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

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Research article

First published 2019-1

A Comparative Review of Marketing Authorization Decisions in Switzerland,the EU,and the USA

Simon Dalla Torre Di Sanguinetto, Esa Heinonen, Janine Antonov [...]

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2017-7

Commentary Regarding Shapiro,“Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?”

David Price

Journal of Diabetes Science and Technology

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Other

First published 2005-08

How FDA currently makes decisions on clinical studies

Robert Temple

Clinical Trials

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Research article

First published 2006-10

Mylan v FDA : Another Court Decision in Favour of ‘Authorised Generics’

Frederick H. Rein, Amanda M. Kessel

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

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Other

First published 2011-09

National Academy Wants FDA to Evaluate Public Health Consequences of Decisions

Biotechnology Law Report

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Research article

First published 2024-3

StockWatch: Madrigal Shares Soar as FDA Nears Historic MASH Decision

Alex Philippidis

GEN Edge

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