A
AERS
Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor new adverse events and medication errors that might occur with these marketed products.
Acknowledgement Message (ICSRACK)
Acknowledgement Message is a generalization of what is commonly called "read receipt". The sender of the message requests a validation notification to be sent and the receiver's mail program generates a reply from which the sender can confirm the authenticity of the content in the message.
C
CIOMS
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. The CIOMS system collects reports of adverse reactions and quality problems, primarily with drugs and medical devices.
D
DTD
Document Type Definition (DTD) defines the legal building blocks of an XML document. It defines the document structure with a list of legal elements and attributes.
E
EDI
Electronic Data Interchange (EDI) refers to the structured transmission of data between organizations by electronic means. It is used to transfer electronic documents from one computer system to another from one trading partner to another trading partner.
EDIINT
Electronic Data Interchange, over the Internet (EDIINT) is the preferred method for exchanging EDI, XML and other data over the Internet.
eMDR
The electronic Medical Device Reporting (eMDR) provides capability to enter data and process the medical device adverse event reports electronically.
ESG
FDA Electronic Submissions Gateway (FDA ESG) enables the submission of regulatory information electronically for review. The FDA ESG provides a centralized, agency-wide communications point for securely receiving electronic regulatory submissions.
I
IND
An acronym for Investigational New Drug, it is process by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
ICHICSR
An acronym for Individual case safety report, it is a standard for capturing information needed to support the reporting of adverse events, product problems or consumer complaints associated with the use of regulated products. The ICSR is used as the baseline for data exchange.
M
MDN
Message Disposition Number (MDN) is a generalization of what is commonly called "delivery receipt". The sender of the message requests a disposition notification to be sent and the receiver's mail program generates a reply from which the sender can learn about the status of the message.
The MDN is a notification on the receipt of an EDI Message returned by the Receiver’s Gateway to the Sender’s Gateway. The MDN concludes a Message Transaction performed between two parties in a Gateway-to-Gateway communication.
MEDWatch
MEDWatch is the Food and Drug Administration’s reporting system for adverse events. The MedWatch system collects reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products.
MHLW
Report ICSR SGML file to the MHLW (Ministry of Health, Labor and Welfare) in Japan in conformity to ICH E2B/M2 Guidelines.
P
PMS
An acronym for Post Marketing Surveillance, this is the practice of monitoring a pharmaceutical drug or device after it has been released on the market.