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  • Regulatory NewsRegulatory News

    FDA releases guidance on inclusion of geriatric information in drug labeling

    The US Food and Drug Administration (FDA) has issued draft guidance on the content and placement of information specific to geriatric patients in drug and biologic labeling.   The guidance document, issued in September 2020, replaces a previously withdrawn guidance document – “Content and Format for Geriatric Labeling” – initially released in October 2001.   The new draft guidance provides examples of specific geriatric use statements and examples of when the FDA...
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    Recon: COVID vaccine makers see EU liability shield; BMS lands FDA priority review for ide-cel CAR-T therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Decision Time Looms for Biotech’s Riskiest Bet ( WSJ ) After bruising rejection, bluebird and Bristol Myers Squibb land ide-cel priority review. But will it matter for the CVR? ( Endpoints ) ( Press ) Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization ( WSJ ) CDC Advisory Panel to Delay Vote on Initial...
  • Feature ArticlesFeature Articles

    Regulatory tools for generic drug companies: Formal FDA meetings and controlled correspondence

    This article discusses formal meetings and controlled correspondence for the generic drug industry and the use of these regulatory tools in the abbreviated new drug application (ANDA) process. The author notes that these tools are useful in understanding the current thinking of the US Food and Drug Administration (FDA) to avoid unexpected delays for product approval as well as expedite faster generic drug approvals.   Introduction Generic drugs are copies of innovato...
  • WHO: Two-thirds of global population now participating in COVAX initiative

    Countries representing nearly two thirds of the world’s population have now signed on to The World Health Organization’s COVID-19 vaccine development and manufacturing accelerator. In all, 64 higher income countries have joined the COVAX facility, with an additional 38 expected to join soon. The United States, Russia and China are not among the countries joining the multinational effort.   World Health Organization (WHO) director-general Tedros Ghebreyesus led a 21 Sep...
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    EMA backs dexamethasone for COVID-19, seven new medicines and consults on ICH Q3D guideline

    The European Medicines Agency’s (EMA) on Friday recommended seven medicines for marketing authorization and began a public consultation on the International Council for Harmonisation’s (ICH) Q3D(R2) guideline on elemental impurities.   EMA also endorsed the use of dexamethasone to treat coronavirus disease (COVID-19) patients who are on oxygen or mechanical ventilation based on results from the RECOVERY trial.   “Published data from the RECOVERY study show that, in...
  • Feature ArticlesFeature Articles

    Manufacturer obligations applying to importers, distributors, or others under MDR and IVDR

    This article discusses issues and requirements spelled out in MDR and IVDR Chapter 2 and that chapter’s Article 16, which applies to manufacturer’s obligations and responsibilities. The author addresses new quality management system (QMS) requirements for repacking and translation of labeling, and the QMS certification obligations. Also covered are cases in which manufacturer obligations apply to importers, distributors, or other persons; changing a device’s intended purpo...
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    First virtual RAPS Convergence draws nearly 1,500 participants, earns praise

    RAPS last week wrapped up its first RAPS Convergence conference to be held completely online. RAPS Convergence is the largest annual gathering of the global healthcare regulatory community and the only US event exclusively dedicated to the regulatory profession. RAPS completely redesigned this year’s conference, transforming what has traditionally been a face-to-face event in a different host city each year, into a live, virtual, interactive experience for the nearly ...
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    Convergence: Global planning is key to successful development of companion diagnostics

    Planning and alignment are the keys to successfully steering companion diagnostics through regulatory processes across the globe, according to experts who spoke at RAPS Convergence 2020.   “The most critical way to develop a companion diagnostic is really a coordinated, co-development model, and this is the most effective path to regulatory approval,” said Ken Butz, associate director of regulatory technical advisors at PPD, and the leader of a session on the evolving ...
  • ReconRecon

    Recon: HHS asserts rulemaking authority over FDA; AstraZeneca releases COVID vaccine trial blueprints

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over FDA ( NYTimes ) ( Endpoints ) ( HHS ) Democratic chairman says White House blocked FDA commissioner from testifying ( The Hill ) A Deal on Drug Prices Undone by White House Insistence on ‘Trump Cards’ ( NYTimes ) Top US Health Officials Tiptoe Around Trump’s Vaccine Timeline ( NYTimes ) Emails Deta...
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    FDA Meeting Types, Explained

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    Data Preparation for Marketing Applications

  • Regulatory NewsRegulatory News

    Convergence: Thinking beyond the registry for real-world device evidence

    Medical device registries can provide rich fields for data mining when real-world evidence is sought. But most medical devices will never land on a registry. Does this mean that these manufacturers will not be able to find a source of real-world data?   Not according to Heather Colvin, who spoke during a real world evidence-focused session at RAPS Convergence 2020. Colvin is the director of evidence and outcomes policy for MD regulatory affairs at Johnson & Johnson. Sh...