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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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    FDA Looks to Modernize Sterile Injectable Inspections

    With an eye toward averting drug shortages and sterility question marks, the US Food and Drug Administration (FDA) is modernizing its inspections program with a new way of assessing, recording and reporting data from surveillance and pre-approval inspections for sterile drugs. The New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a more structured manner for more consistent facility oversight and faster and more ...
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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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    FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues

    The US Food and Drug Administration (FDA) has warned Chinese over-the-counter (OTC) drug and cosmetics maker Bicooya Cosmetics Limited over poor sanitary conditions and data integrity issues at its Zhejiang, China facility. The warning letter comes after a four-day inspection of the facility last May that resulted in FDA placing the firm on import alert in late June. During the inspection, FDA says its investigator "observed rodent feces throughout [the] facility," incl...
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    EMA and FDA to Begin Sharing Commercially Confidential Information

    Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared. As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information. The a...
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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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    FDA Warns Indian Firm for Impeding Inspection

    The US Food and Drug Administration (FDA) in April warned Indian pharmaceutical manufacturing company Vikshara Trading & Investments Ltd for attempting to avoid an inspection by pretending its employees were on strike and for poor conditions inside its facility. According to FDA, the agency cancelled a pre-announced inspection of Vikshara's facility last June after the company said its workers had gone on strike and blocked the entrance to the facility less than 10 days ...
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    A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers

    As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports. Thanks to the Freedom of Information Act, Focus obtained from FDA two lists detailing not only the 86 requests for the Form 483s issue...