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    FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

    The US Food and Drug Administration (FDA) recently opened for comment until 26 August a guideline from the International Council for Harmonisation (ICH) on how to collect safety data in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterized. The 10-page draft of E19, endorsed by the ICH Assembly on 3 April, is part of efforts to reduce the burden on study participants while facilitating studies that can adva...
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    Recon: Roche’s Genentech Strikes Deals With Skyhawk, Sosei Heptares and Convelo Therapeutics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How pharma, under attack from all sides, keeps winning in Washington ( STAT ) 2020 candidates throw punches at drug industry ( Politico ) ( BioPharmaDive ) Democrat Harris unveils plan to lower drug costs, put 'people over profit' ( Reuters ) ( The Hill ) ( Washington Examiner ) ( Harris ) Democratic chair: Medicare negotiating drug prices not moving before Au...
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    Asia Regulatory Roundup: TGA Proposes Ban on Certain Breast Implants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Ban on Certain Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) is planning to cancel the licenses of nine Natrelle textured breast implants made by Allergan. TGA proposed the action, plus the suspension of 16 other devices, after reviewing evidence of links between breast implants and a form of lymphoma.   Ove...
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    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
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    Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA

    Rep. Mike Kelly (R-PA) sent a letter Tuesday to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless questioning why insulin, which has seen dramatic price increases, is not considered a complex generic drug. If FDA were to consider insulin a complex generic, like some other peptides, drugmakers would only need to submit an abbreviated new drug application (ANDA) to win approval for a copycat product, rather than a 505(b)(2) application, which only pa...
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    FDA Looks for New Device Sterilization Methods

    Following the closures of contract sterilization facilities that prompted the US Food and Drug Administration (FDA) to alert to the potential for medical device shortages, the agency launched two public innovation challenges Monday to spur sterilization alternatives and reduce emissions.   The first innovation challenge is intended to identify methods or technologies as alternatives to ethylene oxide (EtO) sterilization, while the second innovation challenge will look ...
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    MHRA Seeks Input on Patient, Public Engagement

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday opened a twelve-week public consultation to gather input on its approach to engaging the public, patients, caregivers and health care professionals.   “We want to adopt a more systematic approach to listening to and involving patients – ensuring that the patient voice is heard when safety issues, concerning medicines and medical devices, are identified and in the licensing of new medicines,” ...
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    EMA Warns of Dosing Errors With Methotrexate Drugs

    The European Medicines Agency’s (EMA) on Friday released a set of recommendations for health care professionals to follow to avoid dosing errors with methotrexate-containing medicines.   The recommendations come after a review of dosing errors related to the drugs by the agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which was prompted by an Article 31 referral by Spain’s Agency of Medicines and Medical Products (AEMPS) last year.   According to the...
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    Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence

    Just over two months ago, the US Food and Drug Administration (FDA) released draft guidance explaining to drugmakers what constitutes real-world data (RWD) and real-world evidence (RWE) and how to submit such data to the agency. The draft guidance spells out what the agency considers to be an RWD source (i.e. electronic health record data, medical claims or billing data, etc.) and what relevant submissions may include RWE (i.e. single arm trials that use RWE as an ext...
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    IMDRF Opens Consultation on Annex Related to Adverse Event Terminology

    The International Medical Device Regulators Forum (IMDRF) proposed a new annex to its adverse event terminology technical document to include medical device parts and components.   Annex G proposes the terminology on medical device parts and components using the same Excel spreadsheet format as Annexes A through F. The proposed document seeks to harmonize definitions for a range of parts, including materials, and components including accessories.   “The terms allow...
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    Recon: Gilead, Galapagos in $5.1B Drug Development Deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead to raise stake in Belgian biotech in $5.1bn deal ( Financial Times ) ( STAT ) ( Endpoints ) ( PMLive ) ( Press ) Lawmakers urge Trump administration to alter trade deal or Americans will pay more for drugs ( STAT ) ( Center for Biosimilars ) AstraZeneca's Farxiga fails to get US approval for Type-1 diabetes ( Reuters ) ( Endpoints ) Eton's conjunctiviti...
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    First FDA-Developed Medical Device Development Tool Receives Qualification

    A tissue mimicking material (TMM) for use in the preclinical development and evaluation of ultrasound medical devices became the first medical device development tool (MDDT) developed by the US Food and Drug Administration (FDA) to receive FDA qualification.   Device developers can use this MDDT to help test the safety of their high-intensity therapeutics ultrasounds (HITU) devices before moving to clinical trials.   With the TMM’s qualification, the MDDT program n...