ELECTRONIC SUBMISSIONS ------------------------------------------------------------------------------------------------------------------------ Advertising & Promotional Labeling E-Submissions for Prescription Drugs Submissions In Electronic Format Compliance Policy Guide: Electronic Records & Electronic Signatures Creating Portable Document Format Reviewer Documents Device Electronic Submissions Dockets Established for 21 CFR Part 11 Guidance Electronic Standards for the Transfer of Regulatory Information ( ESTRI) Electronic Submissions through ESTRI Gateway FAQ Electronic Regulatory Submissions General Considerations Abbreviated New Drug Applications (ANDAs) Annual Reports for New Drug Applications (NDAs) Carcinogenicity Data Drug Master File Investigational New Drug Applications (INDs) Launch Material and Other Submissions to the DDMAC NDA Electronic Submissions Training (NEST) NDA Electronic Data Analysis Training (NEDAT). New Drug Applications (NDAs) Postmarketing Adverse Events Reporting Electronic Review Helpful Links OGD Electronic Submissions

ELECTRONIC SIGNATURES ------------------------------------------------------------------------------------------------------------------------ Electronic Records; Electronic Signatures (21 CFR Part 11)