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  • Regulatory NewsRegulatory News

    Which Region is Better for Diabetes Drug Approvals: US or EU?

    US pharmaceutical regulators at the Food and Drug Administration (FDA) easily best their EU counterparts at the European Medicines Agency (EMA) when it comes to approving new diabetes treatments, a new report claims. The report, issued on 7 July 2014 by the regulatory consulting group Context Matters, looked at a study issued earlier this year in the New England Journal of Medicine (NEJM) which compared new drug approvals by FDA, EMA and Health Canada...
  • Fitch Report Says NME Approvals Plummet at FDA in Q1, but FDA Data Paint Alternate Picture

    When trying to gauge the success of both the US pharmaceutical sector and the US Food and Drug Administration (FDA), one metric usually reigns supreme: approvals. But despite progress by the latter in shoring up its flagging approval numbers in recent years, a new report indicates the first quarter of 2014 was the worst quarter for approvals in almost 15 years. Background FDA approvals over the last decade have experienced their ups and downs. Consider the following ch...
  • FDA Blows Away Rivals in Approving Cancer Therapies

    The public persona of the US Food and Drug Administration (FDA) can ordinarily be described in a word: reserved. Its press releases frequently reveal an agency which hedges its statements, avoids hyperbole, and mostly steers clear of speculation. But every now and again, it feels like bragging a bit. Regulatory Braggadocio Specifically, it feels like bragging about how it compares to its foreign regulatory counterparts like the European Medicines Agency (EMA). While th...
  • EMA Bests FDA in 2013 New Drug Approval Numbers

    If regulation is a numbers game, the European Medicines Agency (EMA) may have just bested the US Food and Drug Administration (FDA) in 2013. One of the best indications that a regulator is performing efficiently is the number of new molecular entities (NMEs) it approves in a given year. An NME is essentially an active substance that has never before been used for a given purpose, requiring new evidence of safety and efficacy. The thinking goes that a regulator that can a...
  • FDA Approvals Strong in 2013, but Far From Highs of 2012

    A new report published by the Center for Drug Evaluation and Research (CDER) shows that while approvals of new molecular entities (NMEs) dipped in 2013 relative to 2012, trends appeared to have held steady compared to the turbulence and uncertainties of the last decade. The report, Novel New Drugs: 2013 Summary , observes that FDA approved 27 new drugs in 2013, down from 39 in 2012 and about even with the 30 approved in 2011. The 2013 total is also higher than th...
  • India’s Health Ministry Acts on CDSCO Reform Recommendations

    India's Ministry of Health and Family Welfare (MHFW) has issued a report recommending the implementation of several reforms to the country's drug approval and clinical trials system. The reforms had originally been submitted to the Ministry by an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, created in response to the Parliamentary Standing Committee on Health and Family Welfare's critical 59th Report on the functioning of India's Central Drugs Standard Contr...
  • FDA Says Focus on Regulatory Science Key to Advancing Personalized Medicine and Helping Patients

    A new report published by the US Food and Drug Administration (FDA) seeks to further advance its frequent narrative that good regulation is good for both business and the American public, this time focusing on how its efforts in the area have advanced personalized medicine. Background The term "regulatory science," which FDA defines as the "science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regula...
  • FDA Argues its NME Approval Record Holds Constant When Adjusted for Quality of Drugs Approved

    Is there an "innovation gap"-that is, a slowdown in the development and approval of truly innovative pharmaceutical products reaching the market-affecting the pharmaceutical industry right now? While the much-discussed theory has more than a few proponents, the US Food and Drug Administration (FDA) isn't one of them, and in a new public missive attempts to pour cold water on something that has "generally been accepted as truth." Background In recent years, FDA has been ...
  • Flurry of Year-End Drug Approvals Makes 2012 Best Year for Approvals Since 1997

    The US Food and Drug Administration (FDA) has ended the year on a high note, approving a flurry of new pharmaceutical products, taking its 2012 approval total to a 15-year high. US regulators approved at least seven high-profile and mostly new drug products during the final two weeks of 2012, including: Varzig (varicella zoster immune globulin preparation) - Cangene Corporation : Approved for reducing the severity of chicken pox infections in high-risk individuals. ...
  • FDA's Two-year Approval Record Marks 15-Year Best, Report Finds

    The US Food and Drug Administration (FDA) has approved the same number of drugs during the 2012 fiscal year as it did in 2011, a new FDA report claims-the best two-year approval record in 15 years. The agency's "Fiscal Year 2012 Innovative Drug Approvals" report notes that FDA has already "used expedited approval authorities and flexibility in advising sponsors on clinical trial design to approve 35 new novel drugs" this past fiscal year (1 October 2011 through 30 Sept...
  • Feature ArticlesFeature Articles

    Perspectives on FDA Review of Medical Devices: Part 2

    The outcome of any US Food and Drug Administration (FDA) submission is never a certainty, but sponsors can enhance their chances of success by optimizing the submission strategy and content, and by minimizing or avoiding the potential submission problems that tend to slow down or prevent the completion of premarket reviews. Consider a Pre-Submission Meeting One particular strategy we have found quite productive, particularly for more-complex or innovative devices, is to...
  • Feature ArticlesFeature Articles

    Perspectives on FDA Review of Medical Devices: Part I

    In recent months, I have attended various medical conferences and trade shows that have highlighted many of the most promising med-tech innovations. From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. Yet, as a regulatory professional, I was struck by the numerous calls for the US Food and Drug Administration (FDA) reform and the claims FDA is st...