• Regulatory NewsRegulatory News

    New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance on the US Pharmacopoeial Convention Pending Monograph Process (USP-PMP), outlining how sponsors can revise or create new monographs so they are harmonized with a new product’s FDA-approved quality and labeling requirements.   Background   New and generic drug applicants and drug master file holders must ensure that a drug product or substance complies with applicable standards in the US...
  • Feature ArticlesFeature Articles

    Comparison of Data Requirements for the Approval of a Biosimilar Versus the Reference Medicine

    This article compares and contrasts several aspects of biological products versus biosimilar products. The author defines both biologics and biosimilars and explains how and why the two differ in terms of their organic natures. She also guides the reader through the biologic vs. biosimilar developmental and testing stages and through agency approval and postmarketing surveillance. The author clarifies important points to consider when developing biologic and biosimilar pro...
  • Regulatory NewsRegulatory News

    AdvaMed Calls for Tweaks to FDA Draft Guidance on Inspections

    In two comments submitted to US Food and Drug Administration (FDA) draft guidance on inspections of medical device establishments, AdvaMed recommended several changes.   The draft guidance, issued in March, seeks to make the processes and standards for FDA inspections of device establishments uniform, per the criteria set forth under the FDA Reauthorization Act of 2017 (FDARA). Yet AdvaMed argues the draft guidance fails to deliver.   “The current wording of th...
  • Regulatory NewsRegulatory News

    EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup

    The European Commission (EC) issued a call for applications to serve on a subgroup that will assist and advise on nomenclature-related issues, including unique device identification (UDI) and surveillance, as part of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).   The 5 July call gives industry associations and other health professionals or stakeholders until 5 August to submit applications. The EC’s Directorate-General for Internal Market, ...
  • Regulatory NewsRegulatory News

    FDA Finalizes Revised REMS Modifications Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized a revision of its guidance on making and submitting modifications and revisions to risk evaluation and mitigation strategies (REMS).   Specifically, the guidance lays out FDA’s policies for REMS modifications and revisions, including what types of changes the agency will consider and the processes and procedures for submitting those changes to the agency.   The 26-page guidance finalizes an earlier vers...
  • Regulatory NewsRegulatory News

    FDA Warns Akorn for Repeat Violations

    Following a more than one-month inspection last summer, the US Food and Drug Administration (FDA) on Tuesday released a warning letter for Akorn’s Somerset, New Jersey manufacturing facility due to cGMP violations. The warning letter, issued 13 June and discussed by Akorn on 25 June, echoes some of the observations made by FDA in a Form 483 for the site last November. FDA specifically raises concerns with the site’s quality system, which “does not adequately ensu...
  • Feature ArticlesFeature Articles

    Curiosity: One of Life’s Most Valuable Commodities

    This article discusses the value in human curiosity for learning, living a more meaningful life and as an important tool for professional success. The author reviews several books on curiosity that outline why we are curious, explains different types of curiosity and suggests how we might not lose our curiosity as we age. Introduction While working for a medical device company, I frequently had the opportunity to interview new job candidates. One question I asked was...
  • Regulatory NewsRegulatory News

    WHO Updates Lists of Essential Medicines, Diagnostics

    The World Health Organization (WHO) on Tuesday released the latest lists of essential medicines and essential in vitro diagnostic (IVD) tests, which can help countries prioritize critical health products.   The updated essential medicines list (EML) adds 51 new medicines, bringing the total to 460 medicines. The updated essential diagnostics list (EDL) adds 115 tests to the 113 tests in the first EDL version , published last May.   The focus of the EML is medici...
  • ReconRecon

    Recon: BioNTech Raises $325M for Immunotherapy Pipeline; J&J Partners With Celsius on Single-Cell Sequencing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Judge Blocks Pharma Prices in TV Ad Rule From Taking Effect ( Focus ) ( NYTimes ) ( Reuters ) ( Endpoints ) Pharma defendants invoke SCOTUS in bid to keep prescription data secret ( Reuters ) GOP senators raise concerns over potential deal to lower drug prices ( The Hill ) Judge dismisses J&J’s request to toss out lawsuit over opioids crisis ( The Guardian ) ...
  • Regulatory NewsRegulatory News

    Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs

    The US Food and Drug Administration (FDA) on Tuesday said it is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after manufacturing deficiencies were found at two of the company’s plants. The FDA action follows Apotex’s initial request to withdraw the ANDAs in January 2018. FDA said it became aware of concerns involving material manufactured at the two Apotex facilities, at least one of which was named in each of the pulled ANDAs....
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Reports Sharp Increase in Applications to Drug Review Center

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Reports Sharp Increase in Applications to Drug Review Center   China’s Center for Drug Evaluation (CDE) has reported a sharp increase in the number of applications it receives. In 2018, CDE received 5,574 applications for technical review, an increase of 47% over the previous year.   The increase is one of many double-digit rises detailed in CDE’s 2018 drug...
  • Regulatory NewsRegulatory News

    Judge Blocks Pharma Prices in TV Ads Rule From Taking Effect

    US District Court Judge Amit Mehta late Monday ruled that the US Department of Health and Human Services (HHS) lacks the authority to require drugmakers to post list prices in pharmaceutical direct-to-consumer (DTC) television advertisements. The HHS rule, which was set to take effect on Tuesday and finalized in May , called for television advertisements for prescription drugs with a list price of $35 or more to contain a statement indicating the Wholesale Acquisition ...