• Feature ArticlesFeature Articles

    March's Regulatory Focus: Regulatory intelligence

    Feature articles during March focused on regulatory intelligence (RI), including first-hand accounts of setting up a dedicated process for RI monitoring and developing an in-house RI database, as well as an examination of the implications of the US Food and Drug Administration’s (FDA’s) new integrated review template for RI. Also included were articles on the importance a global unique device identification (UDI) system, the FDA’s Bad Ad program, and the importance of writ...
  • Feature ArticlesFeature Articles

    The importance of the device label to a global UDI system

    Variance between medical device regulations in different jurisdictions complicates creation of a global unique device identification (UDI) system, causing compliance barriers for manufacturers and adoption barriers for device users. As regulatory agencies advance their UDI initiatives, we reflect on the principles guiding this system not only for regulatory purposes, but as essential to improving the value of healthcare supply chain, clinical, and research data. This artic...
  • Regulatory NewsRegulatory News

    Health Canada drafts guidance on electronic media in labeling

    Health Canada last week launched a public consultation on its draft guidance for drugmakers on incorporating electronic media, such as websites or mobile applications, in prescription drug labeling.   The public consultation runs until 7 May 2021 and seeks feedback from industry, health professionals and the public on the agency’s proposed guidance. The draft guidance is built around Health Canada’s existing legal framework for labeling and explains the agency’s expect...
  • Regulatory NewsRegulatory News

    EMA offers labeling flexibilities for COVID therapeutics

    After providing flexibility on labeling requirements for COVID-19 vaccines last year, the European Medicines Agency (EMA) on Monday offered guidance on when those flexibilities could be applied to COVID-19 therapeutics.   The temporary labeling and packaging flexibilities for COVID-19 vaccines are outlined in a memorandum of understanding between the European Commission and EU member states and a questions and answers guidance from EMA . The flexibilities include al...
  • Feature ArticlesFeature Articles

    December's Regulatory Focus: APL and the role of social media

    December 2020. It’s been just one year since we finished the last Regulatory Focus issue on advertising and labeling, yet it feels like a lifetime. In March, as the true impact of COVID-19 kicked in and we retreated from the office space to our home offices, it was hard to envision how we would prevail, both personally and professionally. But our industry, and particularly regulatory advertising and labeling, did not skip a beat and instead, stayed the course and perseve...
  • Regulatory NewsRegulatory News

    FDA revises draft PLLR guidance

    The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance providing recommendations on the content and format of labeling required under the pregnancy and lactation labeling rule (PLLR).   The draft guidance was first issued alongside the final PLLR in 2014, with the rule itself taking effect in June 2015. The PLLR revised labeling requirements under the 2006 physician labeling rule, to “provide a framework for clearly communicating information ...
  • Feature ArticlesFeature Articles

    Global front-of-pack nutrition labeling schemes: Impact on marketing strategies

    This article discusses the global proliferation of various front-of-pack nutrition labeling systems, launched as a tool to help control and reduce the incidence of obesity and other noncommunicable diseases, such as cardiovascular diseases, some cancers, and diabetes. The author addresses critical changes introduced internationally to food and beverage labels, proposals that are currently under consideration, and key elements companies should be aware of when planning mark...
  • Regulatory NewsRegulatory News

    Eudamed to Launch in 2022 for Both Devices and IVDs

    The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Dev...
  • Regulatory NewsRegulatory News

    OIG Report on FDA’s Postmarket Surveillance of Devices Coming in 2020

    The US Department of Health and Human Services’ Office of Inspector General (OIG) will issue a report next year on the US Food and Drug Administration’s (FDA) postmarket surveillance of medical devices, which has come under fire in recent months. OIG says it will assess and describe how FDA's “established passive postmarket surveillance system” identifies and tracks safety concerns and responds to them. “We will also describe how elements of FDA's newer surveillance ...
  • Regulatory NewsRegulatory News

    2020 Guidance: CDRH Offers a Look at What’s Coming

    FDA’s Center for Devices and Radiological Health (CDRH) on Friday released its FY 2020 draft and final guidance list, which features a few repeats from last year and new drafts coming on device servicing and remanufacturing, unique device identification and patient-reported outcome measures used in device submissions, among others. As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft an...
  • Regulatory NewsRegulatory News

    FDA to Congress: Pediatric Information Lacking in 36% of Relevant Orphan Drug Labels

    In a report to Congress, the US Food and Drug Administration said that there is a public health need for additional pediatric information in labeling for over one-third of approved orphan indications that are relevant in the pediatric population. FDA research, conducted as part of the FDA Reauthorization Act of 2017  (FDARA), found that of all drugs that were approved for an orphan indication between 1 April 1999 and 31 August 2018, a total of 548 orphan indications we...
  • RoundupsRoundups

    Asia Regulatory Roundup: India to Add EU to List of Regions Covered by Clinical Trial Waiver

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Seeks Feedback on Mandatory use of QR Codes on API Packaging   India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API). The Indian government plans to implement the system at the start of April.   Through an amendment to the Drugs and Cosmetics Rule...