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    Public Citizen Petitions FDA to Pull Some IV Solutions

    Consumer advocacy organization Public Citizen on Wednesday petitioned the US Food and Drug Administration (FDA) to immediately require the removal of hydroxyethyl starch (HES) intravenous (IV) solutions from the market because their risks outweigh their limited benefits and there are other, safer alternative IV solutions. According to the petition, there are two main categories of IV solutions: crystalloid and colloid. Colloidal solutions, including HES, have largely the...
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    FDA’s CDER Lays Out Rules for Public-Private Partnerships

    The US Food and Drug Administration (FDA) on Friday published a manual of policies and procedures (MAPP) describing how staff from the Center for Drug Evaluation and Research (CDER) can engage in public-private partnerships and consortia to facilitate, inform, and help the external groups understand CDER’s current thinking in a role separate from any regulatory review process. Under FDA’s Critical Path Initiative , Advancing Regulatory Science Initiative and similar ...
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    FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies

    The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation. “FDA has reconsidered our position on this issue and deemed our concerns from 2001 outdated. We will continue to ...
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    GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info

    Despite recent steps to improve cybersecurity, the US Government Accountability Office (GAO) said Thursday that the US Food and Drug Administration (FDA) needs to better protect industry and public health data. The report, titled “FDA Needs to Rectify Control Weaknesses That Place Industry and Public Health Data at Risk,” offers 15 recommendations for FDA to fully implement its agency-wide information security program. For fiscal year 2015, the agency said it spent $58...
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    Former FDA Deputy Director Charged With Insider Trading for Leaking Non-Public Approval Information

    A former Deputy Director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) was charged on Wednesday for providing tips on drug approvals to three hedge fund managers that made tens of millions off of the non-public information. The Securities and Exchange Commission (SEC) announced the charges of insider trading against two hedge fund managers and their source, Gordon Johnston, who worked for a dozen years at FDA and leaked approval in...
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    European Commission Unveils Four New Public Consultations on Clinical Trials

    The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries of trial results for non-specialists or “laypersons” and definitions of investigational medical products (IMPs) and use of auxiliary medicinal products (AMPs). The consultations offer respondents a chance to weigh in (comments on the four consultations are due by 31 August) o...
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    FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

    The US Food and Drug Administration (FDA) again pushed back (from later this summer until April 2017) its finalization of a contentious rule that would allow generic drug companies to update labels like their brand name counterparts. An FDA spokeswoman told Focus that the new date for the finalized rule is a “projected” date “that may be adjusted to reflect ongoing work,” though she could not offer any specifics on why this date was pushed back for this rule. The pro...
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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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    Biotech Company Settles With SEC Over Failure to Disclose FDA Concerns

    The Securities and Exchange Commission (SEC) on Tuesday settled fraud charges against Massachusetts-based biotech company AVEO Pharmaceuticals for $4 million after three former executives allegedly concealed the US Food and Drug Administration’s (FDA) level of concern about approving the cancer drug tivozanib in public statements. SEC had alleged that AVEO concealed FDA’s concerns with tivozanib in statements to investors by omitting the critical fact that FDA staff had ...
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    Regulators, Industry Weigh in on Proposed EU Orphan Regulation Changes

    As the number of orphan drug approvals continues to rise in the EU, the European Commission is now considering feedback from European governments, regulators and industry on how changes to five aspects of the Orphan Regulation may further incentivize the development of drugs for rare diseases. To date, the commission has authorized 117 orphan medicines, 82% of which consist of new active substances, according to a new report .  And while the number of products authorize...
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    FDA Discusses How to Regulate NGS Tests for Cancer Diagnoses

    The US Food and Drug Administration (FDA) is seeking input on how to regulate next-generation sequencing (NGS) tests that can scan a tumor's genes to guide cancer treatments. At a public workshop at FDA's campus in Silver Spring, MD on Thursday, experts in oncology and NGS discussed some of the challenges and considerations for establishing standards for validating what's known as NGS-based oncology panels or assays. In recent years, increased understanding of genetics ...
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    WHO Declares Public Health Emergency Over Microcephaly, Zika Suspected as Cause

    The World Health Organization (WHO) on Monday declared a public health emergency in response to clusters of microcephaly and Guillain-Barré Syndrome (GBS) in Brazil and French Polynesia suspected to be caused by the Zika virus. "I am now declaring that the recent clusters of microcephaly and other neurological abnormalities reported in Latin America, following a similar cluster reported in French Polynesia in 2014 constitutes a Public Health Emergency of International Co...