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At the time of approval of a new medicine, there are few long-term data on the medicine's benefit-risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient exposure and length of follow-up. This study of the number of patients who had been administered medicines at the time of medicine approval by the European Medicines Agency aimed to determine the total number of patients studied, as well as the number of patients studied long term for chronic medication use, compared with the International Conference on Harmonisation's E1 guideline recommendations.
Pubmed ID: 23526887 RIS Download
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One of the main institutions of the European Union, its job is to represent and uphold the interests of the EU as a whole. It drafts proposals for new European laws. It manages the day-to-day business of implementing EU policies and spending EU funds. The 28 Commissioners, one from each EU member country, provide the Commission''s political leadership during their 5-year term. Each Commissioner is assigned responsibility for specific policy areas by the President. The Commission oversees and implements EU policies by: * proposing new laws to Parliament and the Council * managing the EU''s budget and allocating funding * enforcing EU law (together with the Court of Justice) * representing the EU internationally, for example, by negotiating agreements between the EU and other countries. The Commission is based in Brussels and Luxembourg and has offices (representations) in every EU country and delegations in capital cities around the world.
View all literature mentionsAn agency of the United States Department of Health and Human Services, one of the United States federal executive departments that is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary products. The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. (Wikipedia)
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