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  • Regulatory NewsRegulatory News

    Best of 2017: What Readers Clicked on This Year

    From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published. 10. EMA to Suspend More Than 300 Drugs due to Unreliable CRO Studies Back in March, the European Medicines Agency (EMA) recommended the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies w...
  • Regulatory NewsRegulatory News

    FDA Approves First Generic Version of Gilead's HIV Drug Truvada

    The US Food and Drug Administration (FDA) on Friday announced it has approved Teva Pharmaceuticals' generic version of Gilead's HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate). However, Teva has not said how much its version of the drug will cost or when it will be available to patients. A Teva representative declined to comment other than to say the company had received approval. Truvada and HIV PrEP Truvada was initially approved by FDA in 2004 to ...
  • 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...
  • AIDS Group Wins Bid to Obtain 'Confidential' Data Analysis, Summaries About HIV Drug from FDA

    When it comes to patient groups interacting with the US Food and Drug Administration (FDA), some relationships are more adversarial than others. And while plenty of patient groups have their problems with FDA-its regulatory processes, its standards, its conclusions and its approvals-few do anything to escalate those gripes beyond a letter to the commissioner or a call to their congressperson. And then there's the AIDS Healthcare Foundation (AHF). Background The Washi...
  • FDA Backs HIV Prevention Drug In Letter Denying Citizen Petition

    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 Sciences' Truvada for preventing the transmission of HIV-1. The group, the AIDS Healthcare Foundation (AHF), had filed the petition on 7 March 2012-part of a subsequent campaign by the group to call attention to the drug. In a series of advertisements, AHF asked, "What rotte...
  • WHO Issues Guidance on PrEP Products to Minimize HIV Transmission

    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 individuals. In a statement, WHO said the guidance is based on clinical research indicating the drugs are "both safe for people to use and effective in preventing HIV." Though the drug class is far from a silver bullet, it can still reduce rates of infection by between 40% a...
  • FDA Approves Landmark HIV Prevention Pill

    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 drug with an approved indication to prevent the transmission of the Human Immunodeficiency Virus (HIV). The drug was first approved in August 2004 under priority review for the treatment of existing HIV. FDA said under the new indication, approved 16 July 2012 via a supple...
  • FDA Extends Review of Gilead Sciences' Controversial HIV PrEP Drug Truvada

    The US Food and Drug Administration (FDA) will take an additional three months to review Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/emtricitabine) to assess newly-submitted plans to reduce the possible misuse of the drug, reports The Associated Press . Truvada, currently seeking marketing clearance from FDA to reduce the risk of contracting HIV when used in conjunction with other risk reduction methods, was cleared by an FDA Advisory Com...
  • FDA Panels Clear Arena Pharmaceuticals' Obesity Drug, Gilead Sciences' HIV PrEP

    Advisory Committees for the US Food and Drug Administration (FDA) cleared two high-profile pharmaceutical products on 10 May that would, respectively, help patients to lose weight and prevent patients from contracting the Human Immunodeficiency Virus. Arena Pharmaceuticals' Lorcaserin: The New York Times : "Government advisers recommended approval on Thursday of a weight-loss drug developed by Arena Pharmaceuticals, making it likely that a new obesity trea...