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

Field Safety Notice (FSN)

A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action

Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.

EMA HTA Parallel Scientific Advice

When developing a medicinal product, two milestones are of importance for making its path to the market: the granting of a marketing authorization from regulatory agencies and the proof of the medicinal product’s usefulness to the healthcare system.

European network for Health Technology Assessment (EUnetHTA)

The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as well as a large number of relevant regional agencies and non-for-profit organizations that produce or c

Disease risk-factor reduction claims (RDRC)

Possibly the highest level of medicine-like health claim that can be made on a non-drug product. It describes the propensity for the product or dietary ingredient to aid in the reduction of the risk factors associated with particular diseases.

New Chemical Entity (NCE)

A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products.

ISO 13485

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.).

Notified Body (NB)

Notified Bodies NB are independent testing laboratories or product certifier companies accredited by EU Member States to perform conformity assessment tasks specified in the Medical Devices Directives (i.e. quality system audits, device compliance testing, etc.).

New Drug Application (NDA)

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.

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