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Latest Glossary Definitions
ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and is the most commonly chosen path for companies to meet QMS requirements in major international markets (i.e. Europe, Canada, Japan, Australia etc.).
The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks.
A NDA is the final step formally taken by a drug sponsor, wherein it applies to the Food and Drug Administration (FDA) for the approval required to market a new drug in the U.S.
Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or diagnostics for rare diseases.
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.).
The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III medical devices where no identifiable predicate exists.
The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices.
Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to certification by regulatory authorities.
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.