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Retricted access

Research article

First published 2017-9

Analysis of Review Times for Recent 505(b)(2) Applications

Sharon Sakai, Joseph A. DiMasi, Kenneth A. Getz

Therapeutic Innovation & Regulatory Science

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Other

First published 2007-5

The 505(b)(2) New Drug Application

J. Christopher Prue, Arthur J. Mayorga

Therapeutic Innovation & Regulatory Science

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Other

First published 2002-4

505(b)(2) Applications: History,Science,and Experience *

Gordon Johnston, Roger L. Williams

Therapeutic Innovation & Regulatory Science

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Research article

First published 2011-1

How suitable are the suitability petition and 505(b)(2)?

Nirav Chokshi, Bhaumik Modi

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

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Review article

First published 2019-2

Formulary Considerations for Insulins Approved Through the 505(b)(2) “Follow-on” Pathway

Jack T. Rasmussen, Heather J. Ipema

Annals of Pharmacotherapy

Retricted access

Research article

First published 2021-12

505(b) (2) - A smart pathway to differentiate from competitive,low margin environment of generics

Pooja Rathee, Swagat Tripathy, Sahil Khatter [...]

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

Open access

Research article

First published 2019

Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

Ingrid Freije, Stéphane Lamouche, Mario Tanguay

Therapeutic Innovation & Regulatory Science

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Research article

First published 2012-7

Hybrid or Mixed Marketing Authorization Application in the European Union

Andreas M. Vogel

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-12

What companies need to know about FDA’s Final Rule on ANDAs and 505(b)(2) applications

Paul A Braier

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

Retricted access

Research article

First published 2016-7

An Overview of the Regulatory and Developmental Strategies of Chronotherapeutics

Mohd. Aamir Mirza, Faiyaz Shakeel, Zeenat Iqbal

Therapeutic Innovation & Regulatory Science

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