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    House Committee Probes Restricted Distribution Systems Delaying Generics

    • 24 March 2017
    The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition. In his opening statement, Subcommittee on Health Care, Benefits and Administrative Rules Chairman Rep. Jim Jordan (R-OH) said that some drugmakers are manipulating the regulatory framework to block competitors from accessing the reference drugs they need to conduct bioequivalence testing t...
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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 Touts Growth of Post-Authorisation Study Database

    The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database. The database, referred to as the EU PAS Register (European Union electronic register of post-authorisation studies), is operated by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), and was established with the aim of increasing transparency for post-authorisation studies. The EU Pass Regi...
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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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    Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations

    A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies. The proposed rule, unveiled in August , would require a complete quality system approach for these safety ...
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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 Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions

    The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry with 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations. The recommendations, which have been released on an ongoing basis since 2010, provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). The new guidance is for the following activ...
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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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    FDA Revises Guidance on Safety Testing of Drug Metabolites

    The US Food and Drug Administration (FDA) on Tuesday released revised guidance on recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The revisions mean the new guidance supersedes guidance from February 2008. The guidance has been revised to be in alignment with ICH guidance, known as M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authori...