• Regulatory NewsRegulatory News

    FDA Office of Regulatory Affairs Realignment to Begin in May

    The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren. Shuren made the announcement to members of the House Energy & Commerce Committee on Tuesday at a hearing on the Medical Device User Fee Amendments , which must be reauthorized by 30 Septemb...
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    Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities. Training was cited as PIC/S’ “most important field of activity,” and following the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA), the group says considerations will be made on training inspectors on the revised Annex 1 on steril...
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    UPDATE: Authors for Four US Regulatory Fundamentals Chapters Needed

    • 05 January 2017
    The 10th edition of Fundamentals of US Regulatory Affairs will be published in June 2017. RAPS currently is seeking authors for chapters, which will be due no later than 1 March 2017. If you would like to contribute to this book, please review the list of currently available chapters below and send your CV and your preferred chapter(s) to Pam Jones, senior editor, at pjones@raps.org  or submit a volunteer application online. Authors accepted and deliverin...
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    TrackersTrackers

    Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

    With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical device spaces, for investors, and even for the regulators themselves, Twitter is a great place to catch the day’s breaking news before the headlines are written. (Editor’s Note: This is by no means a complete list and if you’re looking for more than 85 accounts, you’re in...
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    Former Regulatory Affairs Director Charged With Insider Trading

    The US Securities and Exchange Commission (SEC) on Thursday charged Robert Gadimian, former senior director of regulatory affairs for Puma Biotechnology, with making more than $1.1 million thanks to non-public information linked to the company’s breast cancer treatment. The SEC alleges that Gadimian pocketed the illicit profits by secretly purchasing Puma stock and short-term call options based on non-public information he learned about positive developments in two cl...
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    Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book

    • 05 May 2016
    RAPS will be publishing the third edition of Fundamentals of International Regulatory Affairs later this year. We are looking for authors for chapters on general information, pharmaceuticals, biologics and other product types. All medical device chapters have been assigned. Outlines will be due 15 June 2016 and chapters will be due 1 September. If you are interested in participating in this project, please send your CV and the chapter(s) of interest to Pam Jones ...
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    Novartis Signs up for Regulatory Training Program as FDA Looks for More Participants

    The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is looking for additional participants for its Regulatory Project Management Site Tours and Regulatory Interaction Program as Novartis has already signed on to participate. The tours and program are part of efforts by CDER to train and develop its regulatory project management staff to further enhance review efficiency and quality by providing the staffers with a better understanding ...
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    Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Pushes to End Regional Variation in Strength of Clinical Trial Oversight The China Food and Drug Administration (CFDA) has committed to ending region-to-region variation in the strength of clinical trial oversight as it’s found that some regions are failing to comply with the more rigorous approach to clinical trial inspections and data quality. CFDA began its clam...
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    Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery

    The following chapter is an excerpt taken from  Fundamentals of EU Regulatory Affairs, Seventh Edition . Objectives Introduce the problem of falsified medicines Define falsified and counterfeit medicines Define active substances and excipients Explain the aims and scope of the Falsified Medicines Directive ( FMD ) Directive 2011/62/EU ) Identify requirements for different stakeholders in the medicines supply chain arising from the FMD ...
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    RAPS-National University of Singapore Certificate Program Celebrates First Graduating Class

    The Medical Device Regulatory Affairs (MDRA) Graduate Certificate Program , a joint academic program from RAPS and the School of Biomedical Engineering at the National University of Singapore (NUS), graduated its first cohort of 31 students last month. The program was developed in partnership with several of Singapore’s government agencies as part of the country’s efforts to nurture a highly competent regulatory workforce. Singapore has spent much of the past de...
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    FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments

    As part of its shift to increase transparency, the US Food and Drug Administration (FDA) said on Thursday that beginning 15 October it will publicly post individuals' comments on the regulations docket. The new policy could potentially have an impact on lobbyists or other special interest groups submitting comments as individuals. "In 1995, FDA explained that it routinely reviewed all comments for obvious confidential information before placing the comments in the docke...
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    Get RAC Questions Answered at the Regulatory Convergence

    If you are planning to attend RAPS’ upcoming Regulatory Convergence in Baltimore, 24–28 October, and you are thinking about pursuing Regulatory Affairs Certification (RAC) or have questions about the RAC, you should plan to attend one of the conference’s two scheduled RAC mini-sessions. The RAC mini-sessions are 45 minutes long and will be held in between educational sessions on Monday and Tuesday. These interactive sessions will give attendees the opportunity to...