ESG Appendix E: Acronyms

A list of acronyms relevant to the FDA ESG is provided below:

Table E-1: List of Acronyms

Acronym	Phrase
AERS	Adverse Event Reporting System
AS2	Applicability Statement 2
CA	Certificate Authority
CBER	Center for Biologics Evaluation and Research
CDER	Center for Drug Evaluation and Research
CDRH	Center for Devices and Radiological Health
CFR	Code of Federal Regulations
DUNS	Data Universal Numbering System
eANDA	Electronic Abbreviated New Drug Application
eBLA	Electronic Biological License Applications
eCTD	Electronic Common Technical Document
eDMF	Electronic Drug Master File
eIDE	Electronic Investigational Device Exemption
eIND	Electronic Investigational New Drug Application
eNDA	Electronic New Drug Application
EDR	Electronic Document Room
FDA	Food and Drug Administration
FDA ESG	FDA Electronic Submissions Gateway
HTTP	Hyper Text Transfer Protocol
HTTPS	Hyper Text Transfer Protocol Secure
IND	Investigational New Drug
MDN	Message Delivery Notification
OCIO	Office of Chief Information
PDUFA	Prescription Drug User Fee Act
PKI	Public Key Infrastructure
RAM	Random Access Memory
SSL	Secure Socket Layer