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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.
If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. [1] Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over several years. [1]
The reports in FAERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor the safety of products after they are approved by the FDA. If a potential safety concern is identified in AERS, further evaluation might include Epidemiology studies.
It authorizes the FDA to require a responsible person for a drug to conduct a post-approval study or clinical trial of the drug to assess a known serious risk or signals of a serious risk or to identify an unexpected serious risk, to require a postapproval study or clinical trial for an already approved drug only if the Secretary becomes aware ...
The study's lead author stated: "Lawyers are manipulating this system to show increases [in vaccine-related adverse events] that are based on litigation, not health research." [ 13 ] Paul Offit , chief of infectious disease at Children's Hospital of Philadelphia , wrote:
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
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The law also directs the FDA to focus its post market surveillance on higher risk devices, and allows the agency to implement a reporting system that concentrates on a representative sample of user facilities—such as hospitals and nursing homes—that experience deaths and serious illnesses or injuries linked with the use of devices.