• 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...
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    EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

    The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating that, when alternatives do not exist, the appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments. The opinion is part of a process to reevaluate the same conclusion from 2009 that “recognised that animals s...
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    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...
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    FDA Details Combination Product Postmarket Safety Reporting Requirements

    The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting. In a webcast last week, John Weiner, associate director for policy at the Office of Combination Products (OCP), explained which parts of the rule manufacturers should be following now, and which will they will be required to comply with beginning July 2017. Weiner ...
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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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    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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    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...
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    Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices

    A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death. The analysis, published in Nature Biomedical Engineering on Friday, raises questions about the trade-offs between speeding access to new devices and ensuring their safety. Specifically, the authors looked at the number of adverse events reported to the ...
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    FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety

    More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products. The final rule, first proposed in 2009 , which is the first time the agency has issued specific recommendations for combo products, is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/d...
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    Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns

    The Senate on Wednesday passed the 21st Century Cures Act by a vote of 94-5. President Barack Obama praised the bipartisan efforts and said he will sign the bill. The bill’s path to success, following the House’s positive vote last week, took a unique route, with the House also passing a previous iteration back in July 2015, and then the Senate trying to craft its own package of bills, which stalled and looked to be dead as recently as September. The wide-ranging, nea...
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    How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains

    During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories. The 12-page guidance, first proposed in January 2015, notes that the risk of cross-conta...
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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 ...