Latest News
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20 May 2013
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The US Food and Drug Administration (FDA) has announced that it will soon hold the second of at least 20 meetings focused on ways to drive pharmaceutical development in ways that best meet the needs
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Latest News
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14 February 2013
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A new untitled letter sent by US regulators to an Internet domain hosting company alleges that the company marketed an unapproved diagnostic test capable of testing for HIV, thereby violating federal
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Latest News
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29 January 2013
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US regulators are touting the success of a regulatory review program that they say has been responsible for approving dozens of drug products intended for use in developing countries—and in particular
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Latest News
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26 November 2012
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A new draft guidance published by the US Food and Drug Administration (FDA) is seeking to assist in the development of a specific class of product—vaginal microbicides—intended to prevent human
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News
Latest News
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28 August 2012
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The U.S. Food and Drug Administration (FDA) approved a new combination pill to treat HIV-1 infection in adults, according to an agency press release.The new pill, called Stribild, contains two new
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Latest News
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1 August 2012
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There’s a new top threat to the safety of the nation’s blood supply. The Wall Street Journal reports donated blood products containing bacterially contaminated blood platelets have usurped HIV for the
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Latest News
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23 July 2012
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The US Food and Drug Administration (FDA) this week published a citizen petition denial to a group seeking to pre-emptively block the approval of a supplemental New Drug Application (sNDA) for Gilead
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Latest News
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23 July 2012
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New guidance issued by the World Health Organization (WHO) is intended to aid countries in assessing pre-exposure prophylaxis (PrEP) drugs for use in preventing the transmission of HIV in high-risk
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Latest News
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16 July 2012
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The US Food and Drug Administration's (FDA) drug regulatory division announced the approval of a new indication for Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate), making it the first
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Regulatory Update
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6 July 2012
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In a statement on 5 June 2012, the German health technology assessment body Institute for Quality and Efficiency in Health Care (IQWiG) said it would reverse its April 2012 decision not to recommend
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