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    FDA and UK’s NICE Offer Guidance on UTIs and Developing New Treatments

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance for sponsors to help develop antibacterial drugs for women with uncomplicated urinary tract infections (UTIs). The draft focuses on efficacy and safety considerations, including primary efficacy endpoints, as well as pharmacokinetic and dose selection considerations. As far as specific efficacy trial considerations, FDA said sponsors should conduct randomized, double-blind, controlled tria...
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    Updated: Market Exclusivity is not What Attracts Orphan Drug Investment, Research Finds

    The added incentive of seven years of market exclusivity has not been a major driver of investments into orphan drugs, which are used to treat conditions affecting fewer than 200,000 in the US, according to research published in Health Affairs by the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital in Boston. In many cases, pharmaceutical patents render the much-hyped seven years...
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    Upcoming FDA Rulemakings: Device Quality Systems, Post Approval Changes to NDAs and BLAs and More

    The Department of Health and Human Services (HHS) on Wednesday released the spring version of its unified agenda on proposed and final rulemakings, featuring a proposed rule on quality system regulations for medical devices and the de novo qualification process, and a final rule on postmarketing safety reporting regulations for human drugs and biological products, among others. Here’s a rundown of several of the many upcoming rulemakings that could impact pharmaceutical...
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    House E&C Advances Bill With 18 Months Exclusivity as Part of OTC Monograph Reform

    The House Energy & Commerce (E&C) Committee on Wednesday advanced a series of bills directed at combating the opioids epidemic, as well as a bill to create a user fee program for over-the-counter (OTC) monographs. The OTC monograph user fee program would allow the US Food and Drug Administration (FDA) to collect fees from industry in exchange for meeting certain performance commitments for completing those reviews. The bill would add new sections to the Federal Food...
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    Recon: Novartis Makes Payments to Trump Lawyer Following Kickback Allegations in China, Greece and Korea

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA drug shortages: EpiPen Added to List ( FDA ) ( Bloomberg ) ( Reuters ) ( NBC ) Novartis made payments to Michael Cohen ( NY Times -$) ( Stat ) ( Endpoints ) ( Mass Device ) ( S&P Global ) ( Fierce ) ( Fierce ) Jazz Pharmaceuticals to settle U.S. probe for $57 million ( Reuters ) A stealthy Harvard startup wants to reverse aging in dogs, and humans could...
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    Danish Medicines Agency Talks Real-World Data With Japanese Regulators, Signs Confidentiality Agreement With US FDA

    The Danish Medicines Agency said it recently met with officials from the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Copenhagen to discuss the use of real-world data. In March, the Danish agency also signed a confidentiality commitment with the US Food and Drug Administration (FDA) to discuss non-public information. The Danish agency said its primary focus with the MHLW and PMDA officials...
  • FDA Drafts Long-Awaited Guidance on DSCSA Waivers

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to help trading partners in the pharmaceutical supply chain request waivers or exemptions from requirements in the Drug Supply Chain Security Act (DSCSA) of 2013.   The DSCSA, which outlines the steps to build a system by 2023 to identify and trace pharmaceuticals as they are distributed in the US, establishes a process by which an authorized manufacturer, repackager, wholesale distribut...
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    MHRA Charges UK Biopharma Company With Breaching Advertising Regulations

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) this week announced that AstraZeneca partner Leo Pharma paid nine UK-based journalists to attend an event in June 2017 and advise the company on how best to explain the benefits of the dermatology medicine Kyntheum (brodalumab), which had yet to be approved for marketing. MHRA said it was alerted by the Irish Health Products Regulatory Agency to a media advisory board held on 26 June 2017 organized by Leo...
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    Two Years of PRIME Experience: EMA Grants Eligibility to 36 Medicines

    With two years of experience under its belt with the PRIority MEdicines (PRIME) scheme, the European Medicines Agency (EMA) offered its perspective in a new report Monday on a program designed to offer additional support for biopharma sponsors developing products with promising preliminary clinical evidence and the potential to significantly address an unmet medical need. Of the 177 requests for eligibility to PRIME received and assessed since the scheme’s launch in Mar...
  • FDA Preps for OND Modernization

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Friday told participants at the Reagan Udall Foundation’s annual public event about plans to modernize the Office of New Drugs (OND) by as soon as the end of summer. Gottlieb said as many as half of the Center for Drug Evaluation and Research (CDER) staff in senior roles could be retiring in the next five years. Despite recent departures from FDA to industry, Gottlieb called the number who could b...
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    FDA Withdraws Final Rule to Cut Biologics Inspections

    The US Food and Drug Administration (FDA) on Friday withdrew a direct final rule to amend the general biologics regulations on inspection time requirements and to remove inspectors' duties. FDA said in the Federal Register : “The comment period closed April 11, 2018. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.” In January, FDA called the biennial inspection schedule “outdated and unnecessary” because since Ju...
  • Recon: FDA Approves Novartis Combo Therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves Novartis combo therapy for aggressive type of thyroid cancer ( Reuters ) Jury convicts four in CMS-Deerfield insider trading case ( Mass Device ) Ex-Valeant Official Sought ‘Big Payday’ in Bribe Scam, Jury Told ( Bloomberg ) Federal kickback law might be used to bring down drug prices, FDA commissioner suggests ( Stat ) Sarepta adds muscular dystrop...