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Postmarketing surveillance. 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. Since drugs and medical devices are approved on the basis ...
Disease registry. Disease or patient registries are collections of secondary data related to patients with a specific diagnosis, condition, or procedure, and they play an important role in post marketing surveillance of pharmaceuticals. [1] Registries are different from indexes in that they contain more extensive data.
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1] VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that ...
Website. FDA CDRH. The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe ...
Theory of the firm. The theory of the firm consists of a number of economic theories that explain and predict the nature of the firm, company, or corporation, including its existence, behaviour, structure, and relationship to the market. [1] Firms are key drivers in economics, providing goods and services in return for monetary payments and ...
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
Case series. A case series (also known as a clinical series) is a type of medical research study that tracks subjects with a known exposure, such as patients who have received a similar treatment, [1] or examines their medical records for exposure and outcome. Case series may be consecutive[2] or non-consecutive, [3] depending on whether all ...
Postdoctoral researcher. A postdoctoral fellow, postdoctoral researcher, or simply postdoc, is a person professionally conducting research after the completion of their doctoral studies (typically a PhD). Postdocs most commonly, but not always, have a temporary academic appointment, sometimes in preparation for an academic faculty position.