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  • Regulatory NewsRegulatory News

    FDA Begins Adding Suffixes to Newly Approved Biologics' Names

    • 17 November 2017
    The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only adding the suffixes to biosimilars' nonproprietary names since 2015. The first additions of the meaningless suffixes came for Thursday's approval of Roche's Hemlibra (emicizumab-kxwh), one of the first new medicines in nearly two decades to treat people with hemophilia A, ...
  • Feature ArticlesFeature Articles

    The Life and Times of a Promotional Claims Compendium

    This article discusses developing a "promotional claims compendium" to review pharmaceutical marketing materials. It highlights the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization. Introduction Reviewing promotional materials is a necessity in the pharmaceutical industry. Rules and regulations implemented by the US Food and Drug Administration (FDA) regarding pro...
  • Regulatory NewsRegulatory News

    When to Submit a New 510(k): FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidances detailing when a new 510(k) is required for changes made to medical devices or their software. In August 2016, FDA released the two draft guidances, five years after the agency's first attempt to replace its 1997 guidance on 510(k) changes. But the agency withdrew the 2011 draft guidance after Congress ordered it to rethink the policies discussed in that version, which industry complained woul...
  • Regulatory NewsRegulatory News

    TGA Consults on Biological Naming

    Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems. According to TGA, the need for a naming convention that can differentiate biologics from their biosimilar counterparts stems from concerns that adverse events could occur when switching patients between products, though the agency says there has been little evi...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
  • Regulatory NewsRegulatory News

    Capsule Supplier Changes: FDA Offers an Updated Policy

    Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday. Prior Approval Supplement When a drugmaker makes changes to an already approved product, including changes to its specifications, manufacturing process or label, the company must notify FDA of the change. Depending on the seriousness of...
  • Regulatory NewsRegulatory News

    Confusion Pushes FDA to Change Antidepressant’s Brand Name

    The US Food and Drug Administration (FDA) on Monday approved a brand name change for Takeda’s antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from confusion with AstraZeneca’s blood-thinning medicine Brilinta (ticagrelor). The new brand name of Brintellix will be Trintellix, and the tablets will look nearly identical and are expected to be available in June, FDA said. “No other changes will be made to the la...
  • Regulatory NewsRegulatory News

    FDA Offers Final Proprietary Naming Guidance to Minimize Medication Errors

    The final guidance from the US Food and Drug Administration is part of a host of proprietary name evaluation measures from the reauthorization of the Prescription Drug User Fee Act and aims to help reduce medication errors. Although prescription drug names can sound funny or awkward, health care providers often rely on the proprietary name as the critical identifier of the appropriate therapy in a market of tens of thousands of products. Product names that look or soun...
  • Feature ArticlesFeature Articles

    What's in a Name? Nonproprietary Naming of Biological Products

    This article discusses recently published FDA draft guidance on Nonproprietary Naming of Biological Products. What's in a name? Well, everything, since it provides a unique identity. A name may not be important to Romeo and Juliet, but it truly matters when it comes to regulation of biological products. On 27 August 2015, FDA published its long-awaited and much-anticipated draft guidance, Nonproprietary Naming of Biological Products . 1 The draft guidance describes F...
  • Regulatory NewsRegulatory News

    FDA: Brand Name Confusion Led to Dozens of Medication Errors

    The US Food and Drug Administration (FDA) has issued a safety alert for two drugs, Brintellix and Brilinta, after receiving 50 reports of confusion between them caused by similarities in the drugs' names. Background When a new drug is submitted to FDA for review, the agency's Division of Medication Error Prevention conducts a review of the product's proposed brand name. FDA's main concern in reviewing the brand names of drugs is to ensure that a drug's brand name does n...
  • Regulatory NewsRegulatory News

    Senators Question FDA's Authority to Issue 'Placeholder' Name for First Biosimilar

    When the US Food and Drug Administration (FDA) approved the US' first biosimilar product, Zarxio, in March 2015, it gave the drug a unique and temporary nonproprietary name. Now a group of US senators is questioning whether FDA had the legal authority to do so. Background Zarxio is the first drug to be approved under the 351(k) pathway created in 2010 under the Patient Protection and Affordable Care Act . The drug, which is manufactured by Sandoz, is intended to be bio...
  • Regulatory NewsRegulatory News

    FDA Says Nonproprietary Biologics Naming Policy Coming Later This Year

    • 29 April 2015
    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) plans to release five additional guidance documents by the end of 2015, including one on the nonproprietary names given to biological products, it announced Tuesday. Background The 28 April 2015 announcement came in the form of an updated list of guidance documents, known as CDER's "Guidance Agenda." The list is an accounting of all guidance documents the agency plans to release—e...