The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
glossary
Pre-Market Notification (510(k))
The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices. A 510(k) is also…
glossary
Pre-Market Approval (PMA)
The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III medical devices where no identifiable…
glossary
Post-Authorization Safety Study (PASS)
A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming principally to further evaluate the…
glossary
Post-Authorization Efficacy Study (PAES)
A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming principally to further evaluate the…
glossary
Pharmacovigilance System Master File (PSMF)
A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with…
glossary
Pharmaceutical Establishment License (PEL)
Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to…
glossary
Periodic Safety Update Report (PSUR)
The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization. Periodic Safety Update…
glossary
Patient Reported Outcome (PRO)
A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a…
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