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    Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance

    Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information to the US Food and Drug Administration (FDA) are coming to an end, possibly as soon as 2019. On 28 December, FDA released draft guidance on the submission of manufacturing establishment information (MEI) in an electronic format. Twenty-four months after the agency finalizes this guidance, all MEI contained in new drug applications, abbreviated new drug applicat...
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    The Expanding Role of Regulatory Operations: How Technology Advances Have Equipped Operations Teams to Play a New Strategic Role

    This article discusses the expanding function regulatory operations plays within organizations and how their broader responsibilities as process engineers, RIM systems experts and business analysts will play an increasing role in the organization's success. In the 1999 hit comedy Office Space , two consultants (the Bobs) are tasked with weeding out unproductive employees at a fictional software company, Initech. The Bobs kick off their interview of one Initech manager...
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    Transformation Underway in how Regulatory Information is Globally Managed

    This article discusses a new World Class Regulatory Information Management (WCRIM) standard and current industry status. Recent industry surveys have reported gradual increases in regulatory information capability (systems and processes) investment since 2007 with a dramatic leap over the past two years. Regulatory organizations are transforming how they work globally in an increasingly complex regulatory environment with the goal of improving efficiency and reducing c...
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    Former FDA Deputy Director Charged With Insider Trading for Leaking Non-Public Approval Information

    A former Deputy Director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) was charged on Wednesday for providing tips on drug approvals to three hedge fund managers that made tens of millions off of the non-public information. The Securities and Exchange Commission (SEC) announced the charges of insider trading against two hedge fund managers and their source, Gordon Johnston, who worked for a dozen years at FDA and leaked approval in...
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    Public Citizen Sues FDA Over Redacted Advisory Committee Info

    The consumer advocacy group Public Citizen is suing the US Food and Drug Administration (FDA) in federal court over the agency's practice of redacting information in the curricula vitae (CV) of its advisory committee members. Public Citizen alleges that the redactions mask information about these outside experts that could reveal potential biases and provide relevant background on their professional qualifications, according to a complaint filed to the US District Court ...
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    ISO IDMP: Another Compliance Project or a new way of Conducting Business?

    This article discusses Identification of Medicinal Products (IDMP) as a new way of conducting business, the benefits gained by adopting the IDMP model and how IDMP can be implemented to help businesses run more efficiently. To support the continuous improvement of pharmacovigilance oversight within the EU, the European Commission (2012) has mandated pharmaceutical companies to submit product information according to ISO IDMP standards. 1 The standards are global and o...
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    Health Canada Details New Confidential Info Disclosures in Draft Guidance

    Health Canada is proposing to disclose more confidential business information (CBI) to eligible persons for the purpose of protecting or promoting human health or the safety of the public, according to new draft guidance. The disclosure of such CBI, approved under the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa's Law) of 2014, stipulates that the Minister of Health may disclose CBI “about a therapeutic product without notifying the person to whose...
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    EMA’s Open Trial Data Policy After Five Years: Long Waits, Lengthy Correspondence

    The European Medicines Agency’s (EMA) five-year-old policy of allowing some academic researchers and journalists to access what’s considered commercially confidential information in the US has resulted in a lengthy process that can take considerable back and forth correspondence with the agency, according to a new study. Since 2010, EMA has allowed clinical study reports to be subject to its “reactive” freedom of information policy, which makes it the only regulator in t...
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    Questions Remain on How Device Cybersecurity Data Sharing Will Work

    A key component in the US Food and Drug Administration's (FDA) postmarket guidance for medical device cybersecurity is participation in Information sharing analysis organizations (ISAOs), though questions remain about how these organizations will function and be governed. In February 2015, President Obama, through Executive Order 13691 , encouraged the development of ISAOs across various sectors for stakeholders "to share information related to cybersecurity risks and i...
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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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    Book Excerpt: Fundamentals of US Regulatory Affairs, Ninth Edition, Chapter 41: Regulatory Information Resources in Review

    The following chapter is an excerpt taken from Fundamentals of US Regulatory Affairs, Ninth Edition OBJECTIVES Become familiar with information resources relevant to the healthcare regulatory industry Learn where to access and retrieve publicly available government, industry and association resources to build regulatory intelligence Recognize the value of meetings and continued learning programs available for professional knowledge and development ...
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    EMA Gearing up to Publish Clinical Data Ahead of New Clinical Trials Regulation

    The European Medicines Agency (EMA) is moving forward with its plan to release the clinical data used in marketing authorization applications. Background: Clinical Trials Regulation In April 2014, the European Parliament overwhelmingly passed a new regulation governing clinical trials, Regulation (EU) No 536/2015 , repealing Directive 2001/20/EC following a transition period lasting through 28 May 2016. One of the major changes in the new Clinical Trials Re...