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    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...
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    Leveraging digital/social media platforms to meet business goals: A US case study

    This article discusses considerations for compliantly leveraging digital and social media platforms to meet pharmaceutical business objectives in the US. The authors outline the approach of Otsuka America Pharmaceutical Inc in developing processes, reviewing and approving digital/social media content, and electronic Form FDA 2253 submissions of related promotional materials.   Introduction Since the onset of social media in the early 2000s, pharmaceutical manufacture...
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    European Commission reviews impact of orphan, pediatric regulations

    The European Commission on Tuesday published the results of a yearslong evaluation of the EU’s orphan and pediatric medicines regulations it says will be used to guide future legislative changes and shape the EU pharmaceutical strategy.   The more than 100-page evaluation reviews the positive impacts and shortcomings of the orphan regulation, Regulation (EC) No 141/2000 , and the pediatric regulation, Regulation (EC) No 1901/2006 , based on external studies and var...
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    EC Offers New Site Suitability Template Under Incoming Clinical Trial Regulation

    The European Commission (EC) on Tuesday published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which has yet to take effect. The template was developed and endorsed by the EU Clinical Trials Expert Group on 9 October to comply with the new regulation, known as Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use. “However, this templat...
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    New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety

    A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms. The study, conducted by researchers at Harvard Medical School, Northeastern University, Boston Children's Hospital and The Ohio State University, and funded by FDA's Center for Drug Evaluation and Research, looks specifica...
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    IGDRP Offers Guidance for Quality Assessors on Drug Substances

    The International Generic Drug Regulators Programme (IGDRP) on Tuesday released guidance finalized in June to help regulatory agencies’ quality assessors review technical information on active substances. Initially drafted by regulators from Australia, Canada, Singapore and Switzerland, the document provides assistance to quality assessors in reviewing the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs)/Drug...
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    EU Pediatric Regulation’s 10-Year Anniversary Report Highlights Shortcomings

    Ten years ago, the European Commission created a new regulation as part of an effort to try to encourage more pediatric research. But in the years since, companies have been slow to increase their development of treatments for pediatric populations, particularly in oncology, where many of the medicines used were developed in the 1990s, “if they exist at all,” an EC report released Thursday said. The report highlighted that the number of completed pediatric investig...
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    European Commission Adopts Two Acts on GMPs for Medicines

    Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use. One of the acts is an  implementing directive  that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization ( see Article 40 of the Community code Directive (2001/83/EC) ). The ...
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    FDA Enforcement Trends for Broadcast Advertisements

    This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information. Introduction From January 2016 through Augus...
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    Regulating CRISPR: FDA and Industry Offer Perspective

    Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators. What is CRISPR? According to the Broad Institute , CRISPR (pronounced "crisper") stands for Clustered Regularly Interspaced Short Palindromic Repeats, which form the basis for a genome ...
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    Application of EU Clinical Trial Regulation Delayed to 2019

    The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed. "Due to these delays, the EU  Clinical Trial Regulation  will now come into application in 2019 instead of October 2018, as previously scheduled," EMA said Friday. The agency says it will provide an update at the next meeting of the Management Board in October 2017, followi...
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    6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

    When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...