• Feature ArticlesFeature Articles

    OTC monograph reform is now law: What’s next?

    This article discusses the impact of over-the-counter (OTC) monograph reform, part of the recently passed Coronavirus Aid, Relief and Economic Security (CARES) Act . Regulators and public health stakeholders have been championing OTC monograph reform for more than five years. Then, in what seems like a blink of any eye, it is now law, passed by Congress and signed by the President on 27 March 2020 as part of the CARES Act for pandemic relief. The new law reflects the...
  • Regulatory NewsRegulatory News

    FDA seeks withdrawal of heartburn drugs due to new carcinogen concerns

    The US Food and Drug Administration (FDA) on Wednesday requested that all manufacturers of drugs containing ranitidine (commonly known as Zantac and used for heartburn) remove all prescription and over-the-counter (OTC) versions from the market because the carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in samples stored at higher temperatures. The announcement is the most serious in a chain of FDA safety advisories related to NDMA ...
  • Regulatory NewsRegulatory News

    FDA Explains Levels of Impurity Found in Recalled Heartburn Drugs

    Following a series of recalls for the heartburn drug Zantac and other ranitidine drugs due to a genotoxic impurity, the US Food and Drug Administration (FDA) said Friday that the levels of the impurity in ranitidine drugs for heartburn and also in the chemically similar ulcer drug nizatidine “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.” The agency also published a table of the ranitidine and nizatidin...
  • Regulatory NewsRegulatory News

    FDA Floats Idea of a Rating System for Drug Manufacturers

    The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities. “This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, w...
  • Regulatory NewsRegulatory News

    Public Funds Help Late-Stage Development of About 25% of New Drugs, Study Finds

    One in four new drugs approved in the US between January 2008 and December 2017 received direct funding from public resources for late stage research or through spin-off companies created from public research institutions, a study published in the BMJ on Wednesday found.  As the drug pricing debate has accelerated in recent months, the debate over whether public or private entities do the majority of drug development work has continued, with the general assumption tha...
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    RWE to Supplement RCTs: FDA Projects Continue

    The US Food and Drug Administration (FDA) has been working with several different data and research companies to further its understanding of how real-world data (RWD) and real-world evidence (RWE) can help to inform its regulatory decision making. One such company that has signed an RWE research collaboration with FDA is COTA, Inc., which is working on a project related to replicating a breast cancer study. Andrew Norden, chief medical officer of COTA, told Focus ...
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    FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials

    As part of a push to reduce administrative burdens, the US Food and Drug Administration (FDA) on Wednesday finalized guidance on an optional streamlined submission process for determining the risk of an investigational in vitro diagnostic (IVD) in a clinical trial where an investigational IVD is being co-developed with an oncology investigational drug. The submission process, first proposed in draft guidance in April 2018 , is meant to help sponsors determine if an IVD...
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    Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation

    The US Food and Drug Administration (FDA) on Friday warned that breast cancer drugs, Ibrance (palbociclib) from Pfizer, Novartis' Kisqali (ribociclib) and Lilly's Verzenio (abemaciclib) may cause rare but severe inflammation of the lungs that could lead to death. “We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall bene...
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    Do People Understand Cancer Drug Ads on TV? Drugmakers Weigh in on FDA Research

    As television ads for cancer drugs pose the question, “Who wouldn’t want a chance to live longer?” or present statements like: “Living longer is possible,” the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is trying to figure out if consumers can understand these drugs’ specific and often complicated indications supported by different types of endpoints. And now drugmakers Novartis, Merck and Eli Lilly are seeking modifications to ...
  • Regulatory NewsRegulatory News

    EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016. In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case ...
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    FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help sponsors establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.   GnRH agonists and antagonists are a mainstay for treating patients with prostate cancer, FDA says, noting that it is one of the most common forms of cancer in American men.   “New drug applications for GnRH analogues typically rely, in part, ...
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    Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

    Amgen, Merck, Eli Lilly and the Association of National Advertisers on Friday sued the Department of Health and Human Services (HHS) because of a rulemaking that would require pharmaceutical list prices to be shown in direct-to-consumer (DTC) drug advertisements on television. The rule, which was finalized in May and is set to take effect in July, requires that television advertisements for prescription drugs or biological products with a list price of $35 or more con...