• Regulatory NewsRegulatory News

    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...
  • 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...
  • Feature ArticlesFeature Articles

    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...
  • Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

    The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority but critics have derided as the regulation of the practice of medicine. A 24 September warning letter to Texas-based CellTex Therapeutics Corporation references the firm's use of adipose tissue (lipoaspirate) recovered from donors, which is then isolated and cultured into adi...
  • 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 ...
  • Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority

    Should the US Food and Drug Administration (FDA) have the authority to regulate cells derived from-and later put back into-a person? A recent opinion-editorial published in The Wall Street Journal by former FDA Associate Commissioner Scott Gottlieb and Coleen Klasmeier , head of FDA practice at the law firm Sidley Austin LLP, argues FDA's efforts to increase regulatory enforcement against stem cell manufacturers has the potential to backfire against the nascent an...
  • US Court: Stem Cells may be Regulated as Drugs

    • 27 July 2012
    The US District Court in Washington, DC, has ruled that the US Food and Drug Administration (FDA) may legally regulate stem cell therapies as drug products-an opening salvo in what is likely to be a lengthy court battle between the agency and a company accused of violating federal regulations. The entire case results from a 2008 enforcement activity by FDA in which it found Colorado-based Regenerative Sciences to be in violation of federal law. In a 2008 warning let...