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  • Regulatory NewsRegulatory News

    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...
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    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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    GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info

    Despite recent steps to improve cybersecurity, the US Government Accountability Office (GAO) said Thursday that the US Food and Drug Administration (FDA) needs to better protect industry and public health data. The report, titled “FDA Needs to Rectify Control Weaknesses That Place Industry and Public Health Data at Risk,” offers 15 recommendations for FDA to fully implement its agency-wide information security program. For fiscal year 2015, the agency said it spent $58...
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    European Commission Offers Guidance on Standalone Software as a Medical Device or IVD

    The European Commission is offering guidance for device companies and other stakeholders trying to determine if their standalone software should be considered a medical device, in vitro diagnostic (IVD) or neither. As the commission notes, standalone software can directly control an apparatus (e.g. radiotherapy treatment), provide immediate decision-triggering information (e.g. blood glucose meters) or provide support for healthcare professionals (e.g. ECG interpretatio...
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    International Food Regulatory Framework: the Codex Alimentarius Commission

    This article reviews the mission of the of the Codex Alimentarius Commission (CAC), an international body whose mandate is to develop internationally harmonised food safety and quality standards to protect the health of consumers and ensure fair practices in the food trade. Introduction Food standards may be developed at various levels, including national, bilateral, regional and multilateral settings. However, the food standards and related texts developed by the Cod...
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    European Commission to Overhaul Concept of ‘Similar’ Medicines Within Context of Orphan Legislation

    The European Commission on Friday proposed to review the concept of “similar medicinal products” in the context of its orphan legislation as part of a wider effort to adapt the text to technical progress. Fifteen years after the implementation of the orphan legislation, the commission says it is currently launching initiatives to improve the implementation of the regulatory framework with a view to ensuring timely access to medicinal products.  In this context, the Comm...
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    EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations

    The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and  in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released. Following a legal-linguistic review of the two documents planned for September, the Council and Parliament could adopt the two draft regulations by the end of 2...
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    European Commission Unveils Four New Public Consultations on Clinical Trials

    The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries of trial results for non-specialists or “laypersons” and definitions of investigational medical products (IMPs) and use of auxiliary medicinal products (AMPs). The consultations offer respondents a chance to weigh in (comments on the four consultations are due by 31 August) o...
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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...
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    European Parliament Looks to Take Over EMA Fee Process

    The European Parliament has voted to lessen the European Commission’s control of the structure and level of fees charged by the European Medicines Agency (EMA), which may instead be set by members of Parliament and European Union (EU) ministers. The amendment, which was proposed alongside a host of other amendments on fees and EMA-related structures linked to EMA’s founding regulation (No 726/2004), though any changes must be accepted by the EU Council of Ministers. “Me...