• Regulatory NewsRegulatory News

    House Committee Considers Four Device Bills to Add to User Fee Reauthorization

    The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites. The committee discussed the bills with various experts and Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who offered no opposition to any of the measure...
  • Regulatory NewsRegulatory News

    FDA Makes Hearing Aids More Accessible

    In a move intended to improve patient access to hearing aids, the US Food and Drug Administration (FDA) on Wednesday issued an immediately effective guidance that reduces the regulatory requirements for selling certain hearing aids. "Despite the high prevalence and public health impact of hearing loss, only about one fifth of people who could benefit from a hearing aid seek intervention," FDA says. FDA announced that it does not intend to enforce the requirement for Ame...
  • Regulatory NewsRegulatory News

    Updated: FDA Disbands Advisory Committee in Charge of Review of HIV, AIDS Drugs

    The US Food and Drug Administration (FDA) has disbanded its Antiviral Drugs Advisory Committee, a committee charged with the review of products intended to treat HIV and AIDS, and transferred its authority to an existing advisory committee with a new name, the agency announced this week. In a 19 March 2015 posting in the Federal Register , the government's daily record of agency actions, FDA said it was immediately disbanding the committee as it "is no longer needed." ...
  • 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...
  • HIV Drug Development Guidance Revised, Reflecting New Approach to Treatment-Resistant Populations

    US regulators have released a new guidance document aimed at providing clarity to the process of developing drug products to treat-not prevent the transmission of-Human Immunodeficiency Virus-1 (HIV-1), bringing up to date a development paradigm last updated more than a decade ago. The guidance revises Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations for Accelerated and Traditional Approval , a guidance released to the public in 2002. FDA...
  • New Guidance Seeks to Inform Development of Anti-HIV Product Class

    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 immunodeficiency virus (HIV) infections. Vaginal microbicides are chemicals used to treat or prevent infections, and are most commonly physically expressed as topical gels or creams. Researchers have long hoped that vaginal microbicides could be used to prevent the spread of HIV i...
  • 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...
  • US Regulators Approve First Over-the-counter HIV Test Kit

    Regulators at the US Food and Drug Administration (FDA) announced Tuesday, 3 July the approval of an over-the-counter (OTC) home testing kit for the detection of the Human Immunodeficiency Virus (HIV)-the first of its kind to be approved. The test, called the OraQuick In-Home HIV Test, is manufactured by Pennsylvania-based OraSure Technologies, Inc. OraQuick received overwhelming approval from FDA's Blood product Advisory Committee in May 2012, voting 17-0 to recomme...
  • 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...
  • OTC Test for HIV Approved by FDA Advisory Panel

    The US Food and Drug Administration's (FDA) Blood Products Advisory Committee voted 17-0 on 15 May to recommend OraSure's In-Home OraQuick HIV Test, the first such product to be approved for over-the-counter (OTC) testing for the Human Immunodeficiency Virus (HIV). According to clinical studies, the device is 99.98% effective at determining whether or not a person is infected with the HIV virus. The product had been faced with some early concerns about the accuracy of t...