• 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 ...
  • RAPS' LatestRAPS' Latest

    US RAC Prep Webcast Series to Kick Off 15 July

    While the Regulatory Affairs Certification (RAC) exams are experience-based and intended for professionals who have been working in the field for three to five years, don’t misinterpret that to mean you can rely solely on your professional experience and expect to pass with ease. The success rate for the exams is typically between 40% and 50%. When it comes to passing any of the four RAC exams , effective preparation is critical. On 15 July, RAP...
  • Regulatory NewsRegulatory News

    HHS Says it Will Shield Maker of Ebola Therapy ZMapp from Legal Liability

    The US Department of Health and Human Services (DHHS) says it will shield the manufacturer of the investigational Ebola virus treatment ZMapp from legal liability under a federal law intended to incentivize the development of new medical products for medical emergencies. Background Under emergency scenarios—the outbreak of a new disease or a disaster—federal legislation permits the US Food and Drug Administration (FDA) to authorize the use of new medications and medical...
  • 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 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...
  • 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...
  • IOM: In Disaster Situation, FDA Will Be Crucial

    A publication by the US Institute of Medicine (IOM) on the topic of emergency preparedness says the US Food and Drug Administration (FDA) will be crucial to efforts to ensure safe and effective medications make it to consumers during an emergency scenario. While IOM's report, Crisis Standards of Case: A Systems Framework for Catastrophic Disaster Response , places FDA in a key role for carrying out rapid benefit:risk assessments and mitigating legal liability for manufa...
  • EMA Releases Draft Guidance on HIV Prophylaxis

    The European Medicines Agency (EMA) released new reflection paper 15 March on the development of pre-exposure prophylaxis (PrEP) products for Human Immunodeficiency Virus (HIV). The paper, intended for pharmaceutical companies, aims to assist in the development of oral and topical medications to be used as part of an integrated risk-reduction approach. "This reflection paper sets out a consolidated position based on this research, which has culminated in the positive re...