• Regulatory NewsRegulatory News

    Nonefficacy Benefits: Research Evaluates What Companies and FDA Say

    An analysis of new molecular entities (NMEs) approved on the basis of noninferiority trials found that sponsors generally named nonefficacy benefits, while the US Food and Drug Administration (FDA) did so in a minority of cases, according to research letter published Monday in JAMA Internal Medicine . The authors, from the University of Maryland School of Pharmacy in Baltimore and the George Washington University School of Medicine, said their findings are “concerning ...
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    Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

    A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.” The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplom...
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    FDA Continues Steady Reduction of Generic Drug Application Backlog

    As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs). The new data (up to 1 July 2016) reveals that FDA has reduced its ANDA workload by about 500 applications in the first six months of 2016 (the ANDA dashboard recapping 2...
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    Five Years of Cancer Drug Approvals: Most Cost Too Much and Give Us Too Little

    This is the guest post rebuttal (to this post from Mark Shapiro, VP of Clinipace) by Dr. Vinay Prasad, Assistant Professor of Medicine in the Division of Hematology Oncology in the Knight Cancer Institute. Prasad also  holds appointments in the Department of Public Health and Preventive Medicine, and as Senior Scholar in the Center for Health Care Ethics at Oregon Health & Science University. Mr. Shapiro comments on some of the arguments made in our investigation o...
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    Five Years of Cancer Drug Approvals: Pricing, Novelty and Improvement

    Mark Shapiro, vice president of clinical development at contract research organization Clinipace, considers a recent JAMA study on cancer drug pricing in a guest post for  Focus . A rebuttal to the post by one of the authors of the JAMA study, Dr. Vinay Prasad, can be found here . The last five years have been exceptionally busy in terms of oncology drug development. Two interesting articles that reflect back on this period of time were recently published. The firs...
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    Researchers Question FDA's Use of Surrogate Endpoints for Cancer Drug Approvals

    Two researchers are questioning the US Food and Drug Administration's (FDA) use of surrogate endpoints in approving new oncology drugs and the agency's failure to more strictly enforce postmarketing study requirements for these drugs, according to a letter appearing in JAMA Internal Medicine . Drugmakers have increasingly relied on surrogate endpoints to support the approval for new cancer drugs. Instead of demonstrating improvements in overall survival, often called "t...
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    Is a Drug Unsafe or Just Unprofitable? How a Lack of Data Clouds Regulatory Classifications

    Regulatory professionals are frequently concerned with getting pharmaceutical products approved for use and available to consumers. But as a new paper in the Journal of the American Medical Association (JAMA) explains, the way in which drug products are withdrawn from the market can have significant implications for both regulators and patients as well. Background Writing in JAMA Internal Medicine , Vinay Prasad, an official associated with Johns Hopkins University...
  • Study: OTC Drug Advertising Lacks Sufficient Balance of Risks, Benefits

    Advertisements for over-the-counter (OTC) pharmaceutical products routinely discount the risks associated with a product instead of presenting the same "fair balance" approach mandated for prescription products, say researchers. Writing in the Journal of the American Medical Association (JAMA) , lead researcher Jeremy Greene explained that often when prescription drugs achieve OTC status, the drug's risks disappear from the advertising. "A commitment to fair balan...
  • Study: Most Drugs Lacking Information on Adequate Pediatric Use

    • 09 May 2012
    A study conducted by researchers at the US Food and Drug Administration (FDA) finds fewer than half of all pharmaceutical products on the market do not contain any information for how the drug should be used safely in pediatric populations, reports Reuters . The study, published in the Journal of the American Medical Association , notes just 46% of products listed in the electronic Physicians' Desk Reference contained information to ensure safe pediatric use, notes Me...
  • Study: Many Clinical Trials Small, of Poor Quality

    Amidst an explosion in the number of clinical trials registered with US regulatory authorities, a new study analyzing clinical trials conducted in the US has found most of them to be relatively small and of inconsistent-and often poor-quality. The study, Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010 , was published in the Journal of the American Medical Association (JAMA) on 2 May 2012. "Clinical trials registered in ClinicalTrials.go...