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    Cancer Drugs First to Take Advantage of UK Early Access Scheme

    The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly. The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma. Background In March 2014, MHRA ann...
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    New Regulatory Approaches Key to Future of Personalized Medicine

    Personalized medicine has been heralded as the future of medicine, a new way forward that will simultaneously trim healthcare costs and improve care by doing away with ineffective treatments. While these large-scale benefits are still to come, personalized medicine—also called or precision medicine—holds great potential, particularly if governments, researchers, regulators and industry can figure out how best to nurture it. Efforts are underway to promote develop...
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    Poor-Quality Medicines a 'Global Pandemic,' New Research Says

    Poor-quality and falsified medicines are "potentially devastating" to global health, researchers and regulators said on Monday in a collection of articles posted in the American Journal of Tropical Medicine and Hygiene . Background: Counterfeit Drugs Not all poor-quality medicines are created equal. The authors of one of the articles break poor-quality medicines into three categories: falsified (including counterfeit), substandard and degraded. While each of these ca...
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    Citing Disease Transmission Risk, FDA to Require Stronger Labels on Some Diabetes Injectors

    The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices. In a 25 February 2015 safety announcement, FDA said the new warnings are meant to "reduce the serious risk of infection" when users share insulin pens and other injectable diabetes medications, "even [when] the needle is changed." "Sharing pens can result in the sp...
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    FDA's Veterinary Regulators Eye Dozens of Policy Changes in 2015

    The US Food and Drug Administration's (FDA) veterinary regulatory division, the Center for Veterinary Medicine (CVM), plans to release 31 new or updated policies in 2015, it has confirmed. In a notice posted on FDA's website last week , CVM announced top-level details about which guidance documents it plans to release in the coming year. Guidance documents are non-binding expressions of policy, and indicate how FDA wants members of the life science industry to comply wi...
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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...
  • House Committee Unveils Intent to Overhaul FDA Regulatory Framework

    A bipartisan group of legislators on the House Energy and Commerce Committee has launched a new initiative its members are calling the "21 st Century Cures Initiative," aimed at accelerating "the pace of cures and medical breakthroughs in the US." In a statement released on 30 April 2014, E&C committee members Fred Upton (R-MI) and Diana DeGette (D-CO) said they're looking to "broadly collaborate" with federal agencies, patients, scientists, academics and members of...
  • Legislators Seek New Regulatory Tools, Framework for Regenerative Medicine

    New legislation introduced in the House of Representatives this week seeks to develop a comprehensive framework capable of allowing the "rapid approval" of regenerative medicine products by the US Food and Drug Administration (FDA). While the bill, the Regenerative Medicine Promotion Act (RMPA) of 2014 , does not define the term "Regenerative medicine," it is defined by the National Institutes of Health as, "the process of creating living, functional tissues to repair...
  • UK Formally Launches Early Access Pathway for Neediest Patients

    The UK's Medicines and Healthcare products Agency (MHRA) has announced that it had formally opened a new regulatory program intended to allow severely ill consumers earlier access to potentially lifesaving medicines. Background The program, known as the Early Access to Medicines Scheme (EAMS), was first announced in March 2014. As described by the UK's Department of Health, EAMS is intended to make the UK "one of the best countries in the world to capitalize on breakthr...
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    Trends in Personalized Medicine

    As decades of experience have shown, drugs can work very differently in different individuals. Advances in genetic sequencing and genomics made early in the last decade sparked the hope that identifying certain genetic characteristics or biomarkers would yield significant advances in healthcare and give rise to a new era of personalized medicine or, as it is often defined, the practice of administering "the right drug, at the right time, at the right dose, for the right p...
  • 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...
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    Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media

    When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Ne...