Types of Applications

• NDS – New Drug Submission
• SNDS – Supplement to a New Drug Submission
• SNDS-C – Supplement to a New Drug Submission – Conditional
• ANDS – Abbreviated New Drug Submission
• SANDS -Supplement to an Abbreviated New Drug Submission
• NC – Notifiable Change
• CTA – Clinical Trial Application
• CTA-A – Clinical Trial Application – Amendment
• DINA – Drug Identification Number Application
• DINB – Drug Identification Number – Biologics
• PDC – Post DIN Change
• PDC-B – Post DIN Change – Biologics
• PSUR-C – Periodic Safety Update Report – Conditional
• PSUR-PV – Periodic Safety Update Report – Pharmacovigilance
• UD-PV – Undefined Data Pharmacovigilance
• RMP-PV – Risk Management Plan – Pharmacovigilance
• Level III – Post-Notice of Compliance Changes – Level III
• YBPR – Yearly Biologic Product Report

• MPNDS – Pre-NDS Meeting
• MPSNDS – Pre-SNDS Meeting
• MPNC – Pre-NC Meeting
• MPDIN – Pre-DIN Meeting
• PRECTA – Pre-Clinical Trial Application Meeting
• PRNDS – Priority Request NDS
• PRSNDS – Priority Request SNDS
• PAND – Pandemic Application
• DMF Type I – Drug Master File Type I
• DMF Type II – Drug Master File Type II
• DMF Type III – Drug Master File Type III
• DMF Type IV – Drug Master File Type IV
• EU NDS – Extraordinary Use New Drug Submission
• EU SNDS – Extraordinary Use Supplement to a New Drug Submission
• UDRA – Undefined Regulatory Activity
• DSUR – Development Safety Update Report