title: Aerosolized drugs: current regulatory perspective.
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.
authors.affiliation: Regulatory Affairs, North America LLC, Durham, North Carolina 27722, USA. nchew@ranallc.com
authors.forename: N
authors.initials: N
authors.lastname: Chew
mesh_terms: D000280:Administration, Inhalation; D000335:Aerosol Propellants; D000336:Aerosols / Q000592:standards; D017402:Chlorofluorocarbons; D002986:Clinical Trials as Topic; D006801:Humans; D007880:Legislation, Drug; D010126:Ozone; D014480:United Nations; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000335:Aerosol Propellants; D000336:Aerosols; D017402:Chlorofluorocarbons; D010126:Ozone