FDA Guidance for Industry: Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization
Titel:
FDA Guidance for Industry: Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization
Internet:
Herkunft/Verlag:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM478821.pdf
Inhalt:
This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging technology to FDA