FDA Guidance for Industry: Regulatory Classification of Pharmaceutical Co-Crystals
Titel:
FDA Guidance for Industry: Regulatory Classification of
Pharmaceutical Co-Crystals
Internet:
Herkunft/Verlag:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM281764.pdf
Inhalt:
This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms