Term Definition
CMMS NCD United States (US) Centers for Medicare & Medicaid Services National Coverage Determination
EMA APP Approved by the European Medicines Agency for marketing within the European Union.
EMA CE The EMA Conformité Européene Mark indicates that a medical device complies with all of the safety requirements established by the European Union. The CE Mark is required to market a medical device within the European Union.
EMA CHMP The EMA Committee for Medicinal Products is the European equivalent of the Food and Drug Administration Advisory Committee. A positive opinion from the CHMP is the second step in the approval process.
EMA COMP The EMA Committee for Orphan Medicinal Products adopts a positive opinion recommending a pharmaceutical for orphan drug status.
EMA DCP EMA Decentralized Procedure allows companies to obtain the simultaneous authorization of a pharmaceutical in more than one EU country if it has not yet been authorized in any EU country and it does not fall within the mandatory scope of the centralized procedure.
EMA MAA European Medicines Agency – Marketing Authorization Application. This is the first step in obtaining authorization to market a pharmaceutical within the European Union.
FDA ACR Food and Drug Administration Advisory Committee Recommendation – drugs and devices must first be recommended by the advisory committee before final approval by the FDA.
FDA APP Approved by the FDA to be marketed within the United States
FDA BLA A Biologics License Application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce and begins the drug approval process in the US.
FDA BTD Breakthrough Therapy Designation is granted when a new drug is intended to treat a serious or life-threatening disease and data indicates that the new drug provides substantial benefits over existing therapy.
FDA CRL A Complete Response Letter is issued when the FDA requires additional information in the review of an application.
FDA FTD Fast Track Designation is granted when a drug offers unmet medical needs for life-threatening conditions. The goal is to grant approval within six months of this designation.
Term Definition
FDA HDE The Humanitarian Device Exemption is the device version of the orphan drug designation and is granted to devices designed to treat rare diseases.
FDA IDE The Investigation Device Exemption is granted to equipment manufacturers prior to marketing authorization. IDE allows companies to test the product in a limited clinical settings prior to full approval.
FDA IND An Investigational New Drug application is filed when a pharmaceutical company wishes to transport unapproved drugs across state lines for the purposes of conducting multi-state clinical trials. Companies must apply for an IND when a drug is not yet approved for marketing within the United States.
FDA NDA A New Drug Application begins the process of FDA review of a new drug.
FDA ODD Orphan Drug Designation is granted for therapies in rare diseases (less than 200,000 cases).
FDA PMA A Pre-Market Approval application is the first step in the regulatory process for medical devices and allows manufacturers to test the device in a number of medical centers.
FDA PRD FDA Priority Review Designation. This designation is given to investigational compounds that treat serious conditions for which current therapy is inadequate or where a new drug offers a significant potential advancement. PRD means that the FDA will attempt to take action within 6 months of receipt of the application.
FDA QIPD QIDP status provides priority review and a five-year extension of market exclusivity following product approval in the United States.
FDA sNDA A Supplemental New Drug Application is submitted by a pharmaceutical company for any changes in packaging, labeling, dosages, ingredients, or new indications to an already approved pharmaceutical product.
UK NICE The England and Wales National Institute for Health Care Excellence (NICE). NICE looks at pharmaco-economic data and makes recommendations on use of drugs based on a NICE cost/benefit analysis. NICE recommendation occur after a product has been approved by the EMA and the UK drug approval authorities.