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    FDA gives generics updates at DIA town hall

    Officials at the US Food and Drug Administration (FDA) addressed plans to prioritize on-site inspections and gave updates regarding certain new drug applications during a generics-focused virtual town hall convened by the Drug Information Association (DIA) as part of its virtual annual meeting. During the session, regulators also shared post-pandemic learnings, including the importance of international collaborations for generic drug development.   The session inclu...
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    EU Taskforce of Pharma Regulators Issues its First Report on Big Data

    A European drug regulators’ taskforce on big data published its first report on Friday. The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) formed the HMA-EMA Joint Big Data Taskforce to harness the potential of data in development and oversight, starting with the new report. They examined clinical trial data, spontaneous adverse drug reports (ADRs), social media data and real-world data (RWD) to inform the work and reach “an important mileston...
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    2018 in Generic Drugs: Approvals Shine but Questions Remain on Competition

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) this week released its year in review, highlighting another banner year for approvals and new guidance documents. 2018 was the first year of GDUFA II, during which FDA implemented certain new provisions tied to the program and the FDA Reauthorization Act of 2017 (FDARA), including pre-ANDA meetings, reconsideration requests, one-time marketing status updates to the Orange Book and competitive gen...
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    FDA Names New Office of Generic Drugs Director

    In an email to staff on Tuesday, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced that Sally Choe will take over for Kathleen Uhl as Director of the Office of Generic Drugs (OGD) upon Uhl’s retirement at the end of the month after serving more than 20 years at the agency.   “With more than 18 years of experience in global drug development, Sally is an accomplished leader in both governmen...
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    RAPS Releases Results of Compensation Survey of Regulatory Professionals

    RAPS today released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved. RAPS’ 2018 Global Compensation & Scope of Practice Report for the Regulatory Profession aggregates salary data for more than 2,300 respondents from 64 countries and breaks down median and averag...
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    GAO to FDA: Publish Plans to Issue or Revise Guidance on Complex Generic Drugs

    The US Government Accountability Office (GAO) on Tuesday called on the US Food and Drug Administration (FDA) to announce plans to issue or revise guidance for complex generic drugs and FDA said it agrees with the recommendation and is working to do just that. The 50-page GAO report comes as FDA has sought to improve the way it reviews and approves these complex generic drugs, which can have a complex formulation, active ingredient, route of delivery, dosage form or ...
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    CDER Report on Novel Approvals Highlights Firsts in 2017

    2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties. And though the total 46 approvals is the second-highest number of approvals by CDER ever, according to the CDER ...
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    GAO: Retail Drug Price Expenditures Have Nearly Doubled Since 1990s

    The US Government Accountability Office (GAO) on Tuesday released a new report on the pharmaceutical industry's sales and expenses related to research and development (R&D), noting that the amount of money people spend on prescription drugs has nearly doubled since the 1990s, mostly because of brand-name drugs. Retail prescription drug expenditures were estimated to account for about 12% of total personal health care service spending in the US in 2015, up from abou...
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    New E&Y MedTech Report Highlights Growth, Regulatory Questions

    Ernst & Young on Monday released a new report on how the global medical technology (medtech) industry grew by 5% in 2016, with US and EU medtech companies seeing net income increase 17%, though several regulatory and legislative question marks are on the horizon. In addition to the improvements seen in income and revenue growth in 2016 when compared to 2015, the report also shows that overall, US and European medtech financing increased 101% in 2016, to $43.9 billi...
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    EU Health Tech Assessments: Majority Favor Continuing Beyond 2020

    A majority of respondents to a European Commission questionnaire, including pharmaceutical and medical device companies, says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020. The results, revealed in a EC report on Monday, found that almost all respondents (98%) consider it useful to compare whether new health technologies work better, equally well or worse than existing ones, as part of guidance to decision makers. Backg...
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    FY 2016 Generic Approvals by FDA: A New Record Under GDUFA

    The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014 . But that high approval figure for last year also comes as the agency sent more complete response letters (CRLs) than any other year....
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    RAPS' Scope of Practice Survey Shows Regulatory Pros Play Increasingly Strategic Role Compensation Up

    RAPS today released the results of its biennial survey of healthcare product regulatory professionals around the world. The survey asked respondents about their daily work, education and professional backgrounds, and compensation. RAPS has compiled and published key survey results and analysis in its 2016 Scope of Practice & Compensation Report for the Regulatory Profession , which can be downloaded at www.RAPS.org/sop . Among the most significant findings, r...