Post Market Terms (28)

Any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product.

CBER is the FDA center responsible for regulating vaccines, blood products, and certain cellular and gene therapy products.

CDRH is the FDA center that regulates medical devices and radiation-emitting electronic products in the United States.

CDER is the FDA center responsible for evaluating and regulating prescription and over-the-counter human drugs in the United States.

CIOMS guides risk surveillance, reporting discipline, and benefit-risk decision updates.

CPV guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Development SAFETY UPDATE REPORT guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Individual CASE SAFETY REPORT supports pharmacovigilance operations that protect patients and satisfy authority expectations.

Medwatch is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

Nitrosamine RISK Assessment is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

A periodic safety report format harmonized by ICH for presenting comprehensive benefit-risk analysis of medicinal products.

A periodic report summarizing the global safety profile of a marketed medicinal product.

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions.

QPPV guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Quality RISK Management is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

RISK BASED Monitoring guides risk surveillance, reporting discipline, and benefit-risk decision updates.

A drug safety program required by FDA for certain medications with serious safety concerns to ensure benefits outweigh risks.

A Risk Evaluation and Mitigation Strategy (REMS) is an FDA-required safety program used when routine labeling alone is insufficient to manage serious risks.

RISK Management guides risk surveillance, reporting discipline, and benefit-risk decision updates.

A document describing safety activities to identify, characterize, prevent, and minimize risks relating to medicinal products.

RISK Management PLAN UPDATE guides risk surveillance, reporting discipline, and benefit-risk decision updates.

RISK Minimization guides risk surveillance, reporting discipline, and benefit-risk decision updates.

SAFETY SIGNAL is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

SAFETY Specification guides risk surveillance, reporting discipline, and benefit-risk decision updates.

An adverse event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.

The process of identifying new or changing safety information from pharmacovigilance data that may require further investigation.

SIGNAL Management guides risk surveillance, reporting discipline, and benefit-risk decision updates.

SUSAR is a safety governance concept used to detect, evaluate, and mitigate post-market risks.