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  • Regulatory NewsRegulatory News

    Gottlieb Establishes FDA Committee to Confront Opioid Crisis

    Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction." As a first step, Gottlieb announced the establishment of an Opioid Policy Steering Committee to bring together some of the agency’s senior career leaders to explore and develop tools or strategies to confront the crisis. The initial quest...
  • Regulatory NewsRegulatory News

    Senate Committee to Vote on FDA User Fee Reauthorizations

    Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements. The current, five-year agreements are set to expire 30 September 2017, though if Congress fails to act before its summer recess, thousands of FDA employees would receive layoff notices. The proposed reauthorizations, grouped ...
  • Regulatory NewsRegulatory News

    Senate HELP Committee Delays Vote on Gottlieb Nomination

    Senate HELP Committee Chairman Lamar Alexander (R-TN) on Wednesday delayed an expected vote on Scott Gottlieb's nomination to head the US Food and Drug Administration (FDA). Alexander said the vote was being delayed to give senators more time to "consider whatever information they want to consider and fit the schedules of senators who are all over the capital." According to Committee Ranking Member Patty Murray (D-WA), senators would need the extra time to review Gottli...
  • Regulatory NewsRegulatory News

    EMA’s Pediatric Committee Seeks to Tweak ICH Q&A on Nonclinical Evaluation of Cancer Drugs

    The European Medicines Agency’s (EMA) Pediatric Committee has offered a couple of comments, slight tweaks and further suggestions for the International Council for Harmonisation’s (ICH) draft question and answer document on its S9 guideline on the nonclinical evaluation for anticancer pharmaceuticals. The committee points to a couple of references in the Q&A on S9 on the scope of the guideline and the statement that "the need for juvenile toxicity testing sho...
  • Regulatory NewsRegulatory News

    Committee Recommends Adding UDIs to Insurance Claims Forms

    The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms. Specifically, the Accredited Standards Committee X12 recommended that the device identifier portion of a UDI be included when high-risk devices are implanted or removed "due to safety concerns about premature failure." The recommendations are now undergoing a three-month consultation ending on 2 May 2017. Following...
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    FDA To Disclose Unredacted Advisory Committee Members' CVs

    In a move toward more transparency, the US Food and Drug Administration (FDA) on Friday announced it would publicly disclose the unredacted curricula vitae (CVs) of advisory committee members. A consent form saying the member’s CV does not include any confidential information will need to be submitted, FDA said. Background FDA maintains about 50 advisory committees comprised of outside experts who weigh in on scientific and medical issues, and which typically convene ...
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    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

    Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (24 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Comprehensive Technical Guidance on Clinical Trials China Food and Drug Administration (CFDA) has released technical guidance on clinical trials, walking drug developers through the entire clinical research process, from preparing to run a first-in-human trial to designing post-marketing and pharmacogenomic studies. CFDA has created the document to provide ...
  • Feature ArticlesFeature Articles

    A Summary of 10 Years of Paediatric Legislation in the European Union

    This article summarizes 10 years of experience with paediatric regulations in the EU. Introduction Almost 10 years ago, on 27 January 2007, new Paediatric Legislation (PL) came into force that reshaped the regulatory landscape for paediatric medicines in Europe. 1, 2 The objective of this Paediatric Regulation (PR) is to improve the health of children in the European Union (EU) by: facilitating the development and availability of medicines for children from birth ...
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    HHS Inspector General Calls on CMS to Incorporate UDIs Into Claims Forms

    In a letter to the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt on Friday, Department of Health and Human Services (HHS) Inspector General Daniel Levinson calls on CMS to work with the Accredited Standards Committee (ASC) X12 to incorporate unique device identifiers (UDIs) for implantable devices into insurance claims forms. According to Levinson, doing so could help CMS keep track of the costs associated with recalled and defective me...
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    FDA to Hold One Advisory Committee for Each Initial Biosimilar

    The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each of the first new biosimilars for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application. Marjorie Shapiro, chief of the laboratory of molecular and developmental immunology at FDA, told attendees at the annual PDA/FDA conference in Washington, DC, that the first biosimi...
  • Regulatory NewsRegulatory News

    FDA Panel Unanimously Backs Amgen’s Humira Biosimilar

    The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee on Tuesday voted unanimously to support Amgen’s biosimilar for AbbVie’s blockbuster biologic Humira (adalimumab). The vote – 26-0, with no abstentions – followed the release of a positive review from FDA staff, and came after a lot of discussion on whether the data presented by Amgen could be extrapolated to all of the indications that Humira is approved for, as well as questions on analytical ch...