Aerosolized drugs: current regulatory perspective
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Updated: Oct 15, 2026

Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System
Published on: April 6, 2017
1Regulatory Affairs, North America LLC, Durham, North Carolina 27722, USA. nchew@ranallc.com
Abstract:
By understanding the way the regulatory concepts of safety and effectiveness are interpreted by CDER, especially by the Division of Pulmonary Drug Products, value can be added to the data developed. Keeping regulatory requirements in mind during early product development aids rapid evaluation of aerosol drug candidates and can lead to more efficient decisions about further development. Health care practitioners, the medical research community, and patient advocates can and do have a voice in the development of new regulations.
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