Regulatory Terms Starting With M

Market Exclusivity (Exclusivity)

FDA-granted periods during which generic or biosimilar competition is delayed for certain approved drugs and biologics.

Marketing Authorization Application (MAA)

The formal application to the European Medicines Agency or EU national authorities seeking authorization to market a medicinal product in the EU.

Master Protocol (Master Protocol)

A single overarching clinical trial protocol designed to evaluate multiple therapies, multiple indications, or multiple populations in a coordinated framework.

Medical Device Reporting (MDR)

FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.

Medical Dictionary for Regulatory Activities (MedDRA)

A standardized medical terminology used internationally by regulatory authorities and the pharmaceutical industry for coding adverse events and medical history.

Medicines and Healthcare products Regulatory Agency (MHRA)

The United Kingdom's regulatory agency for medicines, medical devices, and blood components.

MedWatch (MedWatch)

FDA's program for reporting serious adverse events, product quality problems, and therapeutic inequivalence for human medical products.

Minimum Anticipated Biological Effect Level (MABEL)

The lowest dose at which a biologic is anticipated to produce any pharmacologically meaningful effect in humans, used as the basis for first-in-human starting dose for high-risk products.