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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: MEPs Plan Amsterdam Trip as Parliament Criticizes EMA Move

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   MEPs Plan Amsterdam Fact-Finding Trip as Parliament Steps up Criticism of EMA Move   European politicians are set to visit Amsterdam to check up on the status of the medicine agency’s relocation to the city. The members of the European Parliament (MEPs) see the visit as a chance to confirm if the move is proceeding “as planned and with no interruption” before finalizi...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    New Developments in Payor Communications: Are 20 Years of Uncertainty Over?

    This article discusses the state of FDA guidance relating to the US Food and Drug Administration Modernization Act (FDAMA-114), particularly in the area of Healthcare Economic Information (HCEI), and looks at the questions requiring clarification in order for industry to be able to effectively change how economic and other clinical information is communicated to payors and similar groups. The author also evaluates elements of FDA's 2017 Draft Guidance. Introduction In...
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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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    Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Prepares Changes to Advertising Complaints Process The Therapeutic Goods Administration (TGA) of Australia is seeking industry feedback on the reform of the advertising complaints management process. TGA is considering either setting up a centralized process for handling complaints or outsourcing some or all of the work to an independent authority and wants to get...
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    European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System A senior politician overseeing the United Kingdom’s exit from the European Union has dismissed the need to retain certain aspects of the country’s current regulatory model post-Brexit. Asked in the House of Commons whether he agreed with industry leaders on the need for the UK to be part of a Europe-...
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    Drug Marketing on Twitter: FDA to Study Space-Limited Communications

    The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited. "The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about the drug are made within character-space-limited communicati...
  • Feature ArticlesFeature Articles

    The Importance of Internal Systems to Support Social Media Campaigns

    This article discusses the importance of internal systems to ensure social media and marketing campaigns are in compliance with FDA requirements. Increasingly and on a daily basis, people are using social media to market drugs, medical devices and other medical products. When we think of social media, we typically think of Facebook and Twitter. However, social media may be considered anything in the public domain, including on a website, TV or radio program where a com...
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    Using Social Media to Promote FDA-Regulated Products - A Balanced Approach is Best

    This article shares some of the current thinking on best practice uses of social media in promoting FDA-regulated products. In today's world, the use of social media in pre- and post-marketing activities for FDA-regulated products must be considered and utilized carefully. Appropriate social media use will help to ensure patient safety by disseminating accurate and complete information about a product and/or health condition, and in doing so, it will meet the requireme...
  • Feature ArticlesFeature Articles

    Pharmaceutical Marketing via Social Media

    This article discusses the ongoing effort by the pharmaceutical industry to use social media as a marketing tool. It presents benefits and limitations of using this form of media and describes recent progress in public communication. Pharmaceutical marketing is the practice of promoting and selling medicines to patients through different media. The broad scope of this definition encompasses all means for the purpose of marketing and sales adopted by a company. A drug c...
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    FDA Warns Two Cadila Manufacturing Plants in India

    Just before the end of 2015, the US Food and Drug Administration (FDA) warned two Indian pharmaceutical manufacturing facilities from Cadila Healthcare for major good manufacturing practice (GMP) violations. The warning letter (not to be confused with the warning letter for another Indian manufacturer that goes by the name of Cadila Pharmaceuticals) caps a year of increased scrutiny for Indian drug manufacturers from FDA. Letter Details In particular, FDA found tha...
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    FDA to its Scientists: Feel Free to Engage on Social Media

    The US Food and Drug Administration (FDA) is now encouraging its employees to use social media in a personal capacity, particularly for sharing information that may benefit public health, as long as employees make clear that their opinions aren’t the views of the agency. The new policy, released last week, clarifies that employees do not need to obtain permission or approval from FDA supervisors or agency management to use social media in a personal capacity, although “e...