FDA Guidance for Industry: Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide
Titel:
FDA Guidance for Industry: Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide
Internet:
Herkunft/Verlag:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079286.pdf
Dokumentenart:
Guidance
Inhalt:
Anforderungen der FDA an wässrige Inhalations-Arzneimittel welche steril hergestellt werden