The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks.
Latest Glossary Definitions
MedWatch is the US Food and Drug Administration's reporting program for product complaints.
Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or diagnostics for rare diseases.
The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III medical devices where no identifiable predicate exists.
In market access and payer evaluation of new drugs, patient reported outcomes are as important for payers as are other “quantitative” measures (Biomarker levels in the blood, survival, radiological imaging, etc.). They allow payers to adequately assess the value that the new drug brings.
The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.
The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices.
A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal products.
Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to certification by regulatory authorities.
FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device applications in the US in the frame of clinical studies (i.e. Investigational Device Exemptions IDE), or premarket regulatory submissions (i.e. 510(k), De Novo, PMA etc.).