• Regulatory NewsRegulatory News

    Cybersecurity: House Committee Looks to Build on Public-Private Partnerships

    The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector. In recent years, cybersecurity has been a growing concern in healthcare, with high profile cyber-attacks and vulnerabilities causing disruptions for insurers , hospitals and medical device makers . The stakes for patients are high too as patient data could be lost or tampered with, hospital services interrupted or patients harmed t...
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    House Committee Probes Restricted Distribution Systems Delaying Generics

    • 24 March 2017
    The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition. In his opening statement, Subcommittee on Health Care, Benefits and Administrative Rules Chairman Rep. Jim Jordan (R-OH) said that some drugmakers are manipulating the regulatory framework to block competitors from accessing the reference drugs they need to conduct bioequivalence testing t...
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    FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

    Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion. The new administration’s impact on FDA was not discussed, though some officials discussed how FDA is moving forward with initiatives begun under President Barack Obama’s administration. Elizabe...
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    Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees

    Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy. “Some argue that individuals and their physicians should be free to make these decisions without relying on FDA to make determinations about marketing approval. However, the complexity of the data as well as examples ...
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    Testing and Implementing a Web-Based, Country Regulatory Information Management System

    This informal case study highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform. Introduction Philips began a collection of country regulatory information on paper almost 20 years ago. Over time, the collection moved to spreadsheets and files on shared servers, and then to the company's intranet. By 2015, it had grown into a site with hundreds of pages of data on countri...
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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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    AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices

    Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions. The draft guidance, released in July and known as “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions,” is meant to bring FDA’s be...
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    FDA Finalizes Two Medical Device Guidelines

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform FDA's benefit-risk determinations. The 62-page guidance on benefit-risk determinations, finalized more th...
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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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    European Regulatory Roundup: EMA to Waive Some Scientific Advice Fees for Accelerated Access Program (9 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts new Guidance on Changing Risk-Management Plans, Manufacturing Sites The European Medicines Agency (EMA) has posted new guidance on post-authorization changes to risk-management plans (RMPs) and manufacturing sites. EMA, which has adopted the policies in an attempt to simplify processes for marketing authorization holders, explained the implications of the guidance...