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    UK to Launch New Office for Market Access

    The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies. A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015. Background When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determ...
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    FDA to Study Effect of Generic Drug Appearance on Patient Adherence

    Does the color, shape or size of a generic drug affect how willing patients are to adhere to existing treatment regimens? The US Food and Drug Administration (FDA) wants to know. Background FDA has long been interested in the physical attributes of drugs, and in particular generic drug products. In December 2013, for example, it released a new guidance document, Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules . In it, FDA explained tha...
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    How can Medical Device Labeling be Standardized? FDA Study Aims to Find Out

    US regulators plan to launch a new study of medical device labeling in the hopes of determining if a standardized format could help healthcare providers to better understand the risks and benefits of a device prior to its use. Background If you purchase a pharmaceutical product in the US, you can be almost certain that the label on that product will look identical to every other drug product you've ever purchased. That's because the US Food and Drug Administration (FDA)...
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    UK Regulator Issues First Positive Opinion in Early Access Program

    Merck’s new skin cancer treatment has become the first product approved under a new accelerated review process by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The product, Keytruda, has been shown to be effective in slowing the progression of advanced melanoma, a deadly form of skin cancer with few treatment options. Accelerated Approval Keytruda is the first product to be approved under MHRA’s early access to medicines scheme (EAMS), whic...
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    FDA to Study Quality of Long-Acting Generic Drug Products, Including Popular Birth Control Drug

    The US Food and Drug Administration (FDA) is prepared to spend nearly a million dollars over the next two years to study the quality and effectiveness of long-acting generic drug products, including levonorgestrel-based birth control products, the agency announced last week. Overview The announcements, made on the National Institutes of Health's (NIH) website, relate to three separate study proposals focused on long-acting (LA) pharmaceutical products: Title Notice...
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    FDA Considers Allowing Drug Companies to Drop Some Warnings in TV Commercials

    The US Food and Drug Administration (FDA) has announced its plans to study whether consumers would benefit if direct-to-consumer television advertising contained a shorter list of major side effects instead of the now-lengthy list of nearly all of them. Background The study, first proposed in February 2014, is meant to address a regulatory hypothesis: That consumers, bombarded with a long list of side effects, might have a difficult time deciding between drugs. In the s...
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    Conflicts of Interest on FDA's Advisory Committees Don't Matter Much, Paper Finds

    Conflicts of interest among members of the US Food and Drug Administration's (FDA) influential advisory committees don't have much of a practical impact on the outcome of voting decisions, new research argues. Background The paper comes as several research papers in recent years have made the opposite case—that advisory committee members with stated conflicts of interest do affect how a committee makes a decision. For example, a September 2014 paper in the journ...
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    Federal Commission Prepares to Weigh in on Ethics of Testing Ebola Treatments

    President Barack Obama's bioethics commission is preparing to weigh in on whether the US Food and Drug Administration (FDA) should require manufacturers of investigational products intended to either treat or prevent the Ebola virus to run clinical trials with placebo controls. Are Placebos Ethical? The issue of placebo controls has been a contentious one to regulators and ethicists around the globe. At issue: Since Ebola has such a high rate of mortality, should all ...
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    FDA Plans Huge Study on How Public Understands Drug Risk

    The US Food and Drug Administration (FDA) is out with yet another proposed study on direct-to-consumer prescription drug advertising—its third proposed study in as many weeks—this time focusing on how patients understand the risks and benefits of drug products. Background FDA frequently studies consumer behavior as it relates to drug advertising. An overview of recent studies is as follows: Date Topic Study Summary January 2012 Corrective Advertising Study...
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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...
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    Does Your Spouse Affect How you Perceive Drug Safety? An FDA Study Aims to Find out

    The US Food and Drug Administration (FDA) has announced another proposed study of consumers who watch drug advertising on TV—the second this week—this time trying to assess how spouses influence how consumers understand a drug's benefits and risks. Background FDA frequently studies consumer behavior as it related to drug advertising. An overview of recent studies is as follows: Date Topic Study Summary January 2012 Corrective Advertising Study to assess wh...
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    Barraged by Drug Ads? FDA Wants to Know How That Makes You Feel—About the Drug

    There's no shortage of pharmaceutical advertising on US television stations. Watch a TV show for long enough, and chances are good you might even see the same drug ad several times. Now the US Food and Drug Administration (FDA) says it's interested in studying whether consumers who view the same drug ad multiple times perceive the safety or efficacy of the advertised drug differently than those who view it only once. Background FDA frequently undertakes studies on direc...