Module 1 2021

Maintaining the IND - Must be updated continually • Types of modifications to IND − New Protocol or Protocol Amendments − Information Amendments • IB updates • New information about study drug (CMC information, nonclinical studies, final clinical study report) • Report new information not ordinarily included in protocol or IND safety report submissions – Changes/updates to contact information, FDA Form 1572s, Letter of cross reference − IND Safety Reports − Annual Reports • Yearly submission, within 60 days of “effective IND” anniversary date • Includes enrollment, demographic and conduct status information for each study • AE summaries (safety reports, deaths, dropouts) • Preclinical study status • DSUR combined • Serious and unexpected Adverse Events (AEs) • Inform FDA and all participating investigators

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Marketing Applications

• New Drug Application (NDA)

• Biologics Licensing Application (BLA)

• Premarket Approval Application (PMA)

• For approved products, e.g.,

• Generics (abbreviated NDA - ANDA) • Biosimilars (351(k) BLA) • Supplements (new indication – sBLA/sNDA)

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