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  • Advocacy Group Pries Additional Details from FDA About Approval of AIDS Drug Truvada

    The AIDS Healthcare Foundation (AHF), a DC-based advocacy group, has won yet another legal battle against the US Food and Drug Administration (FDA), forcing it to turn over significant documents related to the approval of Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/ emtricitabine). Background The legal victory for AHF is its second in the last year. In 2013, FDA announced it would expedite the review of Truvada based on its expected cl...
  • EMA Releases Draft Guideline on Acute Heart Failure Therapies

    The European Medicines Agency (EMA) has released a new draft guideline detailing what information it expects of sponsors developing new therapies to treat acute heart failure (AHF). The guideline , released 15 October, is intended to fill in gaps in its chronic heart failure guidance, explained EMA. AHF is composed of what EMA refers to as a "wide spectrum of symptoms and signs, accompanied by hemodynamic abnormalities and neuroendocrine activation that arise secondary...
  • AIDS Group Calls for Hamburg's Resignation

    The AIDS Healthcare Foundation (AHF) has launched an aggressive public advocacy campaign calling for the resignation of the US Food and Drug Administration's top regulator, Commissioner Margaret Hamburg in response to FDA's approval of the anti-HIV prophylaxis drug Tuvada. In a statement released to the media on 27 March, AHF called on Hamburg to step down "in response to the agency's gross mismanagement of new product reviews and a lack of transparency" at FDA. "Hambu...