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Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked.
A further advantage of the Certification procedure [17] is that it provides the Ph. Eur. Commission [14] with up-to-date information on the quality of substances on the European market, highlighting where Ph. Eur. texts and quality requirements might require revision and helping to ensure that the pharmacopoeia remains state-of-the-art.
Advanced Placement (AP) Art History (also known as APAH) is an Advanced Placement art history course and exam offered by the College Board in the United States.. AP Art History is designed to allow students to examine major forms of artistic expression relevant to a variety of cultures evident in a wide variety of periods from the present to the past.
The EMA approved it in September 2017, for the same indication. [9] This is the first FDA-approved treatment for metastatic Merkel-cell carcinoma, a rare, aggressive form of skin cancer. [ 7 ] Avelumab was developed by Merck KGaA and Pfizer .
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines or devices which have received marketing authorisation or are actively being studied in clinical trials in the European Economic Area (EEA).
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.