• Regulatory NewsRegulatory News

    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...
  • 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...
  • FTC Raises Concerns About Quality, Authenticity of Pet Medications

    The Federal Trade Commission (FTC) has released the draft agenda for an upcoming meeting that could shake up the veterinary pharmaceutical sector. The meeting, "Competition & Consumer Protection Issues in the Pet Medications Industry," was first announced in June 2012, and was called in response to FTC's perception that consumer-focused veterinary medications were subject to anti-competitive pricing and access issues. "American consumers spend a tremendous amount ...
  • Study: FDA Recall Communication System Ineffective, Poorly Designed

    It can be difficult to keep up with the dizzying number of drug recall notices sent by the US Food and Drug Administration (FDA). So difficult, in fact, that the agency seems to miss a significant number of recall notices itself, says a new study. The study, published in the Archives of Internal Medicine, finds FDA's recall information communication systems are sorely lacking, failing to disseminate information for as approximately 20% of all recalled medical products ...
  • EMA Looks to Open Up Clinical Trial Data After Concerns About Tamiflu Raised

    The European Medicines Agency (EMA) announced it is looking to develop a "way forward for publication of full clinical trial data" after concerns were published about selective publication of Tamiflu efficacy data. Tamiflu, which was stockpiled heavily around 2009 due to fears about swine flu, was recently attacked in the medical journal PLoS Medicine by authors Peter Doshi, Tom Jefferson and Chris Del Mar, who claim the drug overstated its effectiveness by hiding cert...
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    Nanomedicine: Current Regulatory Scenario and Prophylactic Regulatory Strategies

    "According to Global Industry Analysts Inc. report on nanomedicine, commercialization of this tiny technology is surging at a steady rate and is expected to exceed $160 billion by 2015." 1 What is Nanomedicine? In simple terms, nanomedicine (NM) is nanotechnology-enabled medicine. 2 It is the science and technology of diagnosing, curing and preventing a disease, repairing damaged tissues and preserving human health using molecular tools and molecular knowledge of the ...