A (5) | B (1) | C (14) | D (2) | E (14) | F (4) | G (1) | H (1) | I (14) | J (1) | L (1) | M (4) | N (4) | O (1) | P (15) | Q (2) | R (2) | S (7) | T (2) | V (1)

Latest Glossary Definitions

MedWatch

MedWatch is the US Food and Drug Administration's reporting program for product complaints.

Orphan Drug Designation (ODD)

Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or diagnostics for rare diseases.

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.

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 imaging, etc.). They allow payers to adequately assess the value that the new drug brings.

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 respect to one or more authorized medicinal products.

Pre-Sub meeting

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.).

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