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Research article

First published 2014-5

USA FDA’s implementation of QbD and GDUFA: A wakeup call for other regulatory agencies across the globe

Manisha Saini, Swagat Tripathy, Harish Dureja

Journal of Medical Marketing: Device,Diagnostic and Pharmaceutical Marketing

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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

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Research article

First published 2017-12

Generic Drug User Fee Act II: The positive features for generic drug industry

Jignesh Prajapati, Darshit Patel

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

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Research article

First published 2019-9

Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics

Jason Woo, Jingyu (Julia) Luan, Zili Li [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2011-10

Globalizing the FDA: Achieving safety,access,and transparency through a comprehensive Generic Drug User Fee Program *

Debbie Jaskot, Gordon Johnston, Marcie E McClintic Coates [...]

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

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Research article

First published 2021-04

Regulating Generic Ophthalmologic Drug Bioequivalence—Envisioning Accessibility for Patients

Markham C. Luke, Darby Kozak

Journal of Ocular Pharmacology and Therapeutics

Search results

USA FDA’s implementation of QbD and GDUFA: A wakeup call for other regulatory agencies across the globe

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

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

Generic Drug User Fee Act II: The positive features for generic drug industry

Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics

Globalizing the FDA: Achieving safety,access,and transparency through a comprehensive Generic Drug User Fee Program *

Regulating Generic Ophthalmologic Drug Bioequivalence—Envisioning Accessibility for Patients