INVESTIGATIONAL NEW DRUG ------------------------------------------------------------------------------------------------------------------------ Content and Format of INDs for Phase 1 Studies of Drugs IND Form Help Pre-IND Home Page Pre-IND Getting Started Pre-IND Additional Information and Resources Page Binder Specifications Pre-IND Product Review Jurisdiction Information for Sponsors Submitting INDs Treatment IND List Allowed to Proceed (To MAR98) IND Review Process CDER Acronym List IND/NDA Jackets/Submission Covers IND Process & Review Procedures MaPP 6030.1 Content and Format of INDs (Phase 1) CMC Content/Format of INDs (Phases 2/3)

NEW DRUG APPLICATION (NDA) ------------------------------------------------------------------------------------------------------------------------ Binder Specifications The New Drug Development Process: NDA Review Process CDER Acronym List