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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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Review article

First published 2025-3

Suitability petitions,its evaluation process and US FDA’s response to the suitability petitions: Insights from the first half of GDUFA III

Nirav Chokshi, Bhaumik Modi, Grishma Raval

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

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Review article

First published 2025-6

Suitability petitions,its evaluation process and US FDA’s response to the suitability petitions: Insights from the first half of GDUFA III

Nirav Chokshi, Bhaumik Modi, Grishma Raval

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

Open access

Research article

First published 2019

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals

Cameron M. Kieffer, Alexis Reisin Miller, Benjamin Chacko [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-11

FDA safety actions for antidiabetic drugs marketed in the US,1980–2015

Christina S. Kwon, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio

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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Other

First published 2008-1

Assessing the Performance of the EMEA's Centralized Procedure: A Comparative Analysis with the US FDA

Laura B. Faden, Kenneth I. Kaitin

Therapeutic Innovation & Regulatory Science

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Research article

First published 2010-10

FDA's Recommendations on the Use of Long-Acting β 2 Agonists in the Management of Asthma

Christie A Robinson

Annals of Pharmacotherapy

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Research article

First published 2013-6

Cold Preparation Use in Young Children After FDA Warnings

Sarah Gard Lazarus, Steven L. Lanski, Ashley S. Smith [...]

Clinical Pediatrics

Free access

Research article

First published 1998-04

Use of Pharmacokinetic Data Under the FDA's Redbook II Guidelines for Direct Food Additives

William L. Roth, John F. Young

International Journal of Toxicology

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