Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of
new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in …

How the Food and Drug Administration (FDA) responds to criticism of its drug safety process
will determine whether drug safety actually improves. Propping up the Office of Drug Safety …

Written by experts in the field of pharmacovigilance and patient safety, this concise resource
provides a succinct, easy-to-digest overview of an increasingly critical area of medical …

Over the years, drug products, including those indicated for diabetes, have been withdrawn
from the marketplace because of quality concerns and/or severe adverse drug reactions …

Purpose Pharmacovigilance monitors the safety of drugs after their approval and marketing.
Timely detection of adverse effects is important. The true relationship between time‐varying …

Adverse drug reactions (ADRs) cause a global and substantial burden accounting for
considerable mortality, morbidity and extra costs. In the United States, over 770,000 ADR …

A decision by the FDA to approve a drug for market is based on a thorough review of that
drug's safety and efficacy to determine whether the benefits outweigh the risks associated …

Introduction Signal detection is the most pivotal activity of signal management to guarantee
that drugs maintain a positive risk-benefit ratio during their lifetime on the market. Signal …

Pharmacovigilance systems around the world have come a long way in the last 60 years.
Systems have evolved from reliance on the individual case safety report (ICSR) of suspected …

We are writing to commend Zannad et al. 1 on their excellent paper. In recent years,
guidance from both the US Food and Drug Administration (FDA) 2 and the European …