Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

•Understand components of postmarketing drug safety surveillance. •Understand regulatory requirements and the role of MedWatch for reporting postmarketing safety information.

FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. Agreements with sponsors to conduct postmarketing studies can be...

2024年8月9日 · What information does the Postmarketing Requirements and Commitments section include? Where does the information in this section come from? How often is this information updated? Can a product...

The focus of many postmarketing studies is on comparing the manufacturer’s drug to competing drugs or testing it for off-label use, rather than on gathering safety data for the drug. The MedWatch system includes a database of unsolicited case reports of ADRs submitted to the FDA by drug manufacturers or healthcare providers (e.g., physicians ...

Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more …

Postmarketing surveillance is a system used by regulators or PV centers to collect information about medications’ safety from the market. This may include a random collection of drug samples from the market to test for quality, stability, and proper storage of medications in drug stores and in community and hospital pharmacies.

Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as …

A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging.

Postmarketing continuation studies, observational surveillance of patients prescribed medications, and data mining of large health center databases and patient registries represent ways that ADRs can be captured following FDA approval of a drug. 11 However, physicians have a special role to play in capturing ADRs. When a patient experiences an ...