PT  - JOURNAL ARTICLE
AU  - Marianne Mann
AU  - Robert J Meyer
TI  - Drug Development for Asthma and COPD: A Regulatory Perspective
AID  - 10.4187/respcare.06009
DP  - 2018 Jun 01
TA  - Respiratory Care
PG  - 797--817
VI  - 63
IP  - 6
4099  - http://rc.rcjournal.com/content/63/6/797.short
4100  - http://rc.rcjournal.com/content/63/6/797.full
AB  - This 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.