This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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The Libyan national action plan has been aligned with WHO five objectives. Analysis of the current situation and addressing the gaps and the needs to reach the main goal “one health” approach involves several national sectors and actors, including human and veterinary health, agriculture and foo...d and drug control center and environmental agencies. Therefore, a large committee of all stakeholders was formed with four technical subcommittees were established to addresses every aspect to contain antimicrobial resistance in the country.
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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins
Official Gazette No 43 of 28/10/2013 | LAW No 74/2013 OF 11/09/2013 ESTABLISHING RWANDA FOOD AND MEDICINES AUTHORITY AND DETERMINING ITS MISSION, ORGANISATION AND FUNCTIONING
Official Gazette No Special of 17/01/2013 | LAW No 47/2012 OF 14/01/2013 RELATING TO THE REGULATION AND INSPECTION OF FOOD AND PHARMACEUTICAL PRODUCTS
You don't always need antibiotics when you're sick—only for infections caused by bacteria. And overuse is causing a global health problem.