Chapter 4 - European Union Regulations The European agency for the evaluation of medicinal products is today known as the European Medicines Agency (EMA). From its establishment in 1995 to ... JB Wilson - Elsevier Inc. 被引量: 2发表: 2011年 Regulatory Considerations for Early Clinical Developme...
The European Medicines Agency (EMA) has a legal mandate that includes authorisation of vaccines, risk management of vaccines (post-authorisation data collection and risk minimisation), collection of safety data and post-authorisation safety and efficacy studies. The EMA's remit also includes monitoring...
In 1996, in the USA, 68% of people disposed of medicines down the toilet (Kuspis and Krenzelok1996), and from 100 tested pharmacies, only 3% had a special protocol for expired medications (mostly returning to the producer). In 2007, the first federal guidelines were introduced which recomm...
particularlyin vitro andin silico approaches, have been topics of significant interest and importance. Regulators are actively discussing these trends at conferences like ACT and across the broader scientific community. One clear thing, however, is that regulatory ag...
A stool bank is ideally entwined with a clinical microbiological department as the expertise and equipment to perform both various screening tests, and to process faecal suspensions is already present. As FMT is not yet an approved, treatment modality by the European Medicines Agency (EMA) or US...
Prescribing information from the European Medicines Agency, the German Federal Institute for Drugs and Medical Devices, and the US Food and Drug Administration was also screened for pharmacogenetic guidance. Results | The literature review revealed 20 guideline publications elucidating 43 drugs with ...
REGISTER TO DOWNLOAD FOR FREE Share Cite Advertisement Advertisement Author Information Show + 1. Introduction Nanotechnology is the science of manipulating matter where at least one dimension is in the nano-scale. Nanotechnology is a very promising field to the medicinal and pharmaceutical sectors,...
In March 2013, the European Medicines Agency (EMA) issued a draft guideline for public comment on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy [7]. The community stakeholders believed this draft guideline did not adequately address the...
TPO-RAs have dramatically changed the treatment modality of ITP, making the avoidance of immunosuppressive agents possible in disease management. The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved 3 TPO-RAs for the management of persistent or chronic ITP: eltrom...
In Flanigan’s proposal, institutions such as the Federal Drugs Administration (FDA) and the European Medicines Agency (EMA) would act as certification bodies. Their role would be to test drugs and issue recommendations based on the results of their testing. The main difference between this and ...