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Drug Development for Asthma and COPD: A Regulatory Perspective.
Marianne Mann1, Robert J Meyer2
1Dr Mann is an independent clinical/regulatory drug development consultant in Highland, Maryland. mann612@verizon.net rjm7cd@virginia.edu.
Respiratory Care
|May 26, 2018
Summary
This review clarifies regulatory pathways for developing drugs for asthma and chronic obstructive pulmonary disease (COPD) for US clearance. It highlights key challenges and lessons in drug development for these respiratory conditions.
Area of Science:
- Regulatory Science
- Pharmacology
- Pulmonology
Background:
- Asthma and COPD require effective drug therapies.
- Navigating regulatory pathways is crucial for drug approval.
- Inhaled drug development presents unique challenges.
Purpose of the Study:
- To explain regulatory terms and pathways for US drug clearance for asthma and COPD.
- To clarify key clinical regulatory challenges in drug development for these conditions.
- To provide insights into generic inhaled drug development.
Main Methods:
- Review of regulatory guidelines and terminology.
- Analysis of clinical regulatory challenges for asthma and COPD drugs.
- Case examples illustrating key lessons in drug development.
Main Results:
- Explanation of basic regulatory terms and clearance pathways.
- Identification and clarification of overall and drug-class-specific regulatory challenges.
- Discussion of generic inhaled drug development considerations.
Conclusions:
- Understanding regulatory aspects is vital for successful asthma and COPD drug development.
- Key challenges can be navigated with strategic planning and adherence to guidelines.
- This review enhances appreciation for the regulatory perspective in respiratory drug development.
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