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The US Food and Drug Administration has announced new final guidelines on HIV prevention, following the recent efforts by US President Donald Trump to eliminate the HIV epidemic in America.
Guidance on product development for pre-exposure prophylaxis and pediatric product development is provided to badist sponsors with clinical and non-clinical recommendations, particularly for the development of systemic drugs.
Trump's HIV initiative comes after the US Centers for Disease Control and Prevention (CDC) releases a new report showing that the rate of HIV infections in the United States has stopped falling.
The report, which examines the most recent data on HIV trends from 2010 to 2016, shows that the number of new HIV infections began to stabilize in 2013 after several years of decline.
The FDA's first long-acting drug prevention guideline for the prevention of badually acquired HIV infection, called PrEP drugs, discusses the agency's current thinking on the design of clinical trials.
The second document, which provides general recommendations on the development of antiretroviral drugs for HIV-positive children, indicates when to start the development of pediatric formulations and start pediatric studies and provides information on the right approach to use when engaging subjects in pediatric studies.
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