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  • Regulatory NewsRegulatory News

    Sanofi, CDC and FDA Work to Avoid Yellow Fever Vaccine Shortage

    To head off an impending shortage of YF-VAX, the only US-licensed vaccine for yellow fever, Sanofi Pasteur, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are working to provide travelers with an alternative vaccine. In the coming months, Sanofi will begin importing Stamaril, a yellow fever vaccine developed from the same substrain as YF-VAC, and will distribute it to select clinics around the US. While Stamaril is ...
  • Regulatory NewsRegulatory News

    FDA Approved Nearly All Expanded Access Requests in FY2016

    The US Food and Drug Administration (FDA) granted more than 99% of requests for patients to access unapproved drugs and biologics in fiscal year 2016, according to data released last week. Through FDA's expanded access program, the agency allows patients with serious or life-threatening diseases to access unapproved drugs. Under the program, physicians can request access to a drug for individual patients or a group of patients under an expanded access investigational ne...
  • Regulatory NewsRegulatory News

    EU Parliament Committee Backs Report to Increase Access to Medicines

    The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions. The draft , which a spokeswoman for the European Parliament told Focus that a final version will be made public by the end of this week, covers a menagerie of differ...
  • Regulatory NewsRegulatory News

    BMS' Opdivo Wins UK EAMS Approval for Hodgkin's Lymphoma

    The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday accepted Bristol-Myers Squibb's Opdivo (nivolumab) to its early access to medicines scheme (EAMS) to treat relapsed or refractory Hodgkin's lymphoma. Previously, MHRA granted access to Opdivo under EAMS for patients with certain types of lung cancer, kidney cancer and melanoma. Background In March 2014, MHRA announced it was launching EAMS, saying it would allow earlier access to potentially...
  • Regulatory NewsRegulatory News

    UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years

    The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms. Specifically, the report proposes the development of an "accelerated access pathway" that would help speed up new technologies, including drugs, devices and diagnostics with the potential to provide significant benefi...
  • Regulatory NewsRegulatory News

    Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices

    The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday, with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs. The call for more compulsory license...
  • Regulatory NewsRegulatory News

    FDA Looks to Revitalize Compassionate Use Program With Simplified Form, Final Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized two question and answer guidance documents on charging for investigational drugs and expanded access for the compassionate use of investigational drugs for those with life-threatening diseases or conditions, as well as a new streamlined form for applying for expanded access. The new form, known as the Form FDA 3926, is part of an expedited process to help patients gain access to drugs that are still in clini...
  • Regulatory NewsRegulatory News

    FDA Draft Guidance to Assist CMS With IDE Coverage Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS). While an agreement has been in place between the two agencies for more than two decades, FDA says it has run into issues with some devices not easily fittin...
  • Regulatory NewsRegulatory News

    FDA Official Dispels ‘100 Hours’ Myth on Time it Takes to Fill Out Compassionate Use Form

    The simplification of the US Food and Drug Administration’s (FDA) compassionate use process (announced last February and expected to be finalized very soon) may not actually be all that much of a simplification in terms of the amount of time it takes a physician to fill out the form, an FDA official told Focus on Tuesday. Richard Klein, director of the Patient Liaison Program in FDA’s Office of Health and Constituent Affairs, explained to Focus , following Monday’s ...
  • Regulatory NewsRegulatory News

    Expedited Compassionate Use for Investigational Drugs Coming Soon, FDA Says

    The fight over patients gaining access to investigational drugs via the compassionate use process is expected to get a lot easier in the near future, just as the US Food and Drug Administration’s (FDA) nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better. Compassionate use, also known as expanded access, is a process by which physicians can request that FDA allow the use o...
  • Feature ArticlesFeature Articles

    Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

    This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers who would like to enter this geographical market. In addition, solutions to maximize the product development strategy are discussed with the intention of bridging regulatory and market access gaps. The rapid diffusion of health technologies has presented governments with unprecedented challenges to provide high quality an...
  • Regulatory NewsRegulatory News

    FDA’s Nonprofit Arm Plots Out New Compassionate Use Navigator

    Patients and physicians desperate for access to a potentially life-saving investigational drug will be able to take some solace in the fact that the US Food and Drug Administration’s (FDA) nonprofit, known as the Reagan-Udall Foundation, is currently working on an online tool to help aid the process of obtaining what are known as "compassionate use" or "expanded access" treatments. The small foundation, which is currently operating with six employees, has drafted a plan ...