Search results with tag "Ind investigational new drug"
Regulatory Strategy for Pre-IND Meetings with FDA: Why ...
www.biologicsconsulting.comIND Investigational New Drug application (also synonymous with "Notice of Claimed Investigational Exemption for a New Drug"). (CDER Guidance Document on Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs or 21 CFR 314.312.) PDUFA Prescription Drug User Fee Act
COMMONLY-USED ABBREVIATIONS AND ACRONYMS IN …
www.rochester.eduIDS Investigational Drug Service IEC Independent Ethics Committee IND Investigational New Drug INDSR Investigational New Drug Safety Report IO Institutional Official IP Investigational Product IRB Institutional Review Board ... NDA New Drug Application NTF Note to …
COMIRNATY (COVID-19 mRNA VACCINE) RISK …
www.ema.europa.euinterventional post-approval safety studies that include paediatric subject aged 5 to < 12 years old, as requested. ... FDA (US) Food and Drug Administration GLP good laboratory practice HbA1c glycated haemoglobin ... IND investigational new drug LNP lipid nanoparticle