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ESG Appendix F: Acronyms

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

Table F-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

JCE

Java Cryptography Extension

JRE

Java Runtime Edition

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

 

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