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- Marianne Mann and Robert J Meyer.
- Dr Mann is an independent clinical/regulatory drug development consultant in Highland, Maryland. mann612@verizon.net rjm7cd@virginia.edu.
- Respir Care. 2018 Jun 1; 63 (6): 797-817.
AbstractThis review addresses drug development intended to support United States clearance for asthma and COPD by explaining basic regulatory terms and broadly discussing the regulatory pathways to clearance. Some of the key clinical regulatory challenges that are faced by drugs for asthma and COPD are explained and clarified, both overall and by class of drug, citing relevant examples that emphasize key lessons. Generic drug development of inhaled drugs is also addressed. The purpose of this review is to provide the reader with a greater understanding and appreciation of asthma and COPD drug development from the regulatory perspective.Copyright © 2018 by Daedalus Enterprises.
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