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Review article

First published 2023-6

Abbreviated new drug submission approval process: An overview

Sonali S Amrutkar, Sanjay B Patil, Atish S Mundada

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

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Other

First published 2009-5

A Proposal for a Parallel Submission Process for New Drug Applications and Health Technology Assessment in Taiwan: A Win-Win Solution

Yen-Huei Tarn, Herng-Der Chern

Therapeutic Innovation & Regulatory Science

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Research article

First published 1993-4

CANDA Overview: What Should a CANDA Look Like?

William P. Accomando

Therapeutic Innovation & Regulatory Science

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Research article

First published 1994-4

What is the Future of the Canda at FDA?

Robert A. Bell

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019-3

An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application

Philip T. Lance, Ruth V. Greenaway, Brian Edwards

Therapeutic Innovation & Regulatory Science

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Research article

First published 1978-7

Microfiche Submissions for Original New Drug Applications

Irene H. Gring, Gary T. Kester

Therapeutic Innovation & Regulatory Science

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Research article

First published 1996-1

The Value of Candas in Drug Development

Stephanie Kirk

Therapeutic Innovation & Regulatory Science

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Research article

First published 1996-03

Pharmaceutical Evaluation of New Drug Submissions for Metered-Dose Inhalers—Canadian Style

John Webb

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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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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Research article

First published 2004-02

FDA Issues Final Rule on Patent Listing Requirements and 30-Month Stays of Approval Following Submission of Abbreviated New Drug Applications

Barry J. Marenberg

Biotechnology Law Report

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