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    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 ...
  • Regulatory NewsRegulatory News

    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...
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    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...
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    FDA Issues New Guidance on Conflict of Interest for Advisory Committee Members

    The US Food and Drug Administration (FDA) on Tuesday issued a new draft guidance detailing its approach to determining whether advisory committee members can participate in decisions when the appearance of a conflict might signal an actual conflict of interest. FDA maintains around 50 advisory committees, comprised of experts from outside the agency, to weigh in on specific scientific and medical issues. These committees are typically convened when FDA wants input on a n...
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    Woodcock: Antibiotics Pipeline is 'Fragile and Weak'

    At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health. In its 2014 Antimicrobial Resistance: Global Report on Surveilla...
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    FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest

    The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest. Richard Page, chair of the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, currently serves as chairman of the Circulatory System Devices advisory committee, which reviews and evaluates data concerning the safety and effective...
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    Public Citizen Sues FDA Over Redacted Advisory Committee Info

    The consumer advocacy group Public Citizen is suing the US Food and Drug Administration (FDA) in federal court over the agency's practice of redacting information in the curricula vitae (CV) of its advisory committee members. Public Citizen alleges that the redactions mask information about these outside experts that could reveal potential biases and provide relevant background on their professional qualifications, according to a complaint filed to the US District Court ...
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    Senate Committee Advances Five More Bills as Part of Medical Innovation Package

    The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill. Wednesday marked the third and final hearing by the committee, which is still grappling with a fight over $50 billion in additional mandatory funding for the National Institutes of Health (NIH) that’s supported by Senate Democrats. “With its 21st C...
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    Academic DMD Experts Criticize ‘Errors’ in FDA Ad Com Briefing Documents

    More than 35 medical professors and experts have criticized the US Food and Drug Administration’s (FDA) review of a Duchenne Muscular Dystrophy (DMD) drug, citing errors in the agency’s advisory committee meeting briefing documents. At issue is Sarepta’s drug eteplirsen, which the company is seeking approval as the world’s first treatment for DMD, a rare and fatal genetic disorder afflicting about 15,000 boys in the US. The drug was initially supposed to go before the Pe...
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    Senators Slam Execs of Shkreli's Former Company Over Arbitrary Price Hike on Lifesaving Drug

    The Senate’s Special Committee on Aging held its second hearing on pharmaceutical pricing on Thursday, this time taking shots at executives of Martin Shkreli’s former company Turing Pharmaceuticals, which only exists because of a monopoly and 5,000% price hike on a toxoplasmosis drug first approved more than 50 years ago. The first panel of witnesses included a couple whose newborn was diagnosed with toxoplasmosis but after their insurers denied coverage for the drug, kn...
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    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...