FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Here you can find informations to laws &policies, compliance action, ....
Three Years After Enactment of the Drug Quality and Security Act
Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins
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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FEY ENFOMASYON POU MOUN K’AP RESEVWA AVEK MOUN K’AP BAY SWEN OTORIZASYON POU ITILIZASYON IJANS (EUA) POU VAKSIN MODERNA COVID-19 POU ANPECHE CORONAVIRUSDISEASE 2019
(COVID-19) NAN PERSONN 18 ANE AK PI GRAN
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.
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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English Manual and Guideline on World about Food and Nutrition, Health and Epidemic; published on 30 Nov 2021 by USAID
Report: A survey conducted among the 27 high MDR-TB burden countries.
March – July 2015
Stop TB Partnership in collaboration with Medecins Sans Frontieres (MSF).
Accessed November 2017.
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination
Accessed: 08.10.2019
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
Division of Tuberculosis Elimination.
A survival guide for clinicans.
3rd edition.
WHO recommends that pre-exposure prophylaxis (PrEP) be offered as an additional prevention choice for HIV-negative individuals at substantial risk of HIV infection as part of combination prevention approaches.
HIV drug resistance has been rarely reported among PrEP users who tested HIV positive i...n randomized controlled trials or open-label studies. However, PrEP-selected HIV drug resistance could potentially negatively impact the effectiveness of treatment options among PrEP users who acquire HIV, since there is a potential for overlapping resistance profiles between antiretroviral drugs used for both PrEP and first-line antiretroviral therapy.
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The goal of this Global Action Plan is to articulate synergistic actions that will be required to prevent HIVDR from undermining efforts to achieve global targets on health and HIV, and to provide the most effective treatment to all people living with HIV including adults, key populations, pregnant ...and breastfeeding women, children and adolescents. The Global Action Plan has five strategic objectives: 1) prevention and response; 2) monitoring and surveillance; 3) research and innovation; 4) laboratory capacity; and 5) governance and enabling mechanisms.
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