glossaire.png
Glossary
With plenty of acronyms, procedures or references, the regulatory and market access
environments are sometimes perceived as daunting. Deciphering the language is the
start to finding one’s path.
A (3) | C (9) | D (2) | E (8) | F (4) | I (8) | M (3) | N (4) | O (1) | P (12) | Q (2) | R (1) | S (6) | T (1) | V (1)

Latest Glossary Articles


Patient reported outcomes (PRO)

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

European Medicines Agency (EMA)

- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.

Medical Device Software

A "medical device software”, refers to a computer application that meets the legal definition of a medical device and is not a part of any distinct product.

De Novo

The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices without a predicate as class III.

Pre-Market Notification (510(k))

The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices.

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 predicate exists.

Pages