• 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...
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    FDA Commissioner Nominee Faces Limited Opposition From Senate Committee

    The Senate Health, Labor, Education & Pensions Committee on Wednesday offered praise and only a few muted attacks against Scott Gottlieb, President Donald Trump's nominee to be the next commissioner of the US Food and Drug Administration (FDA). While Democrats focused their questions in the hearing on Gottlieb’s conflicts of interest, how he’ll bring down drug prices and solve the opioid crisis, his work as a consultant and employee of pharmaceutical and biotech companie...
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    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...
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    House Hearing Focuses on Harm Done by Drug Price Spikes

    The highly anticipated House Oversight Committee hearing on Thursday was not without its fireworks, though beyond the airing of a lot of discontent, few new options for halting drug price increases were brought to the table. About an hour into the hearing, Martin Shkreli, former CEO of Turing Pharmaceuticals, who previously called the increase in price of a toxoplasmosis drug a “very handsome investment,” was escorted out after he used his Fifth Amendment rights to avo...
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    Senators Hint at Confirmation of Califf as Next FDA Commissioner

    Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him. Califf did his best to quell any concerns over industry influencing his decisions as head of the agency and the majority of senators at the hearing seemed confident that his experience makes him the right...
  • Feature ArticlesFeature Articles

    Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings?

    This article discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting. Many regulatory changes have impacted the US Food and Drug Administration (FDA) approval process for new drugs and medical devices, including the requirement from the Food and Drug Administration Amendments Act for an Advisory Committee review. Advisory Committees provide the agency with advice from outside experts on issues related to drugs, biological prod...
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    What Did You Say? FDA Plans Study on How Hearing Loss Affects Drug Ad Understanding

    The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising. Background The study, announced in a 24 June 2015 posting in the Federal Register , is somewhat similar to other direct-to-consumer (DTC) drug advertising studies proposed by FDA in the last few years, including studies on how adolescents understand risk in drug ad...
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    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...
  • House Legislators Set to Grill FDA on FDASIA Progress

    It's been more than a year since legislators passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law, and now those same legislators want to know: How is the law doing? Background: FDASIA's User Fee Provisions FDASIA , passed in July 2012, contains provisions that can generally be lumped into two broad categories: user fee programs and reforms. To the former (Titles I-IV), FDASIA reauthorized two major user fee programs, the Prescripti...
  • 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...
  • Brazilian House Holds Hearing on Anvisa Regulatory Authority

    The Committee on Social Security and Family of Brazil's House of Representatives held a hearing on 9 May 2013 on the scope of regulatory authority of Brazil's National Health Surveillance Agency (Anvisa) with one question in mind: Does Anvisa have too much regulatory authority? The deputy director of Anvisa, Neilton Araújo, argued that several bills introduced in the Brazilian Congress to cut back the agency's regulatory authority would in fact be a setback for ...