Regulatory Guidance

Food and Drug Administration

FDA Center for Drug Evaluation and Research

IPAC-RS International Pharmaceutical Aerosol Consortium on Regulation and Science

Medicines and Healthcare Products Regulatory Agency (MHRA)

Product Quality Research Institute (PQRI)

United States Pharmacopeia

Relevant Guidance Documents

Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action

Inhalation Drug Products Packaged in Semipermeable Container Closure Systems

Integration of Dose Counting Mechanisms into MDI Drug Products

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing and Controls Documentation

Nasal Spray and Inhalation Solution, Suspension and Spray Drug Products - Chemistry, Manufacturing and Controls Documentation

Sterility Requirement for Aqueous-based Drug Products for Oral Inhalation - Small Entity Compliance Guidance