• RAPS' LatestRAPS' Latest

    Considering Risk Evaluation and Mitigation Strategies (REMS)

    Every drug comes with some risk. The key issue for regulators, drugmakers, healthcare professionals and patients alike is whether the likely benefit is greater than the risk. This is the question reviewers at the US Food and Drug Administration (FDA) must grapple with in determining whether or not to approve a new product or to leave an already approved product on the market in light of new information about adverse events or other potential negative consequences. In some...
  • FDA Looking to Develop Further REMS Guidance, Release Issue Paper

    The US Food and Drug Administration (FDA) is planning a workshop to gather feedback and information it can use to develop guidance for industry on the best practices for assessing goals associated with Risk Evaluation and Mitigation Strategy plans. The workshop, announced in a 2 May Federal Register posting, will take place on 7 June 2012. "The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, th...
  • EC: SCENIHR Issues Memorandum on Europe's Scientific Risk Assessment Process

    A memorandum issued by the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is intended to provide transparency to stakeholders on the Committee risk assessment process.  Risk assessments inevitably involve human scientific judgments and there are stressors to which humans may be exposed. The memorandum is intended to complement the draft SCENIHR report on the identification of emerging issues and the work of SCE...
  • Industry Comments Indicate Displeasure with Medication Guides, FDA Looking at Single-Page Versions

    • 26 April 2012
    Comments on the US Food and Drug Administration's (FDA) Medication Guide requirements for prescription drug labeling indicate displeasure with the requirements, which are referred to as onerous, costly, excessive, poorly executed and otherwise burdensome. The comments, contained in FDA's Federal Register posting, entitled Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labelin...
  • Feature ArticlesFeature Articles

    Regulatory Environment Changes Affect REMS

    To maintain the appropriate regulatory strategy for a product, it is important to stay abreast of continuing changes in the regulatory environment and applicable regulatory requirements. Knowing when regulatory requirements have changed because authorities have deemed an alternative to be sufficient to achieve the same goals can reduce wasted effort and costs for sponsors. One US Food and Drug Administration (FDA) requirement that has undergone an important change is th...
  • Hamburg: Nanotechnology Regulation Likely to Become 'More Nuanced,' Outlines Regulatory Approach

    • 23 April 2012
    After releasing new nanotechnology standards for food and cosmetic products, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg says the agency's approach to the regulation of nanotechnology products is likely to become "more nuanced" over time. Writing in the journal Science , Hamburg writes the agency has "long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies." "Nanotechnology is not unique in thi...
  • FDA Plans Study on How Obese Patients Make Decisions, Perceive Risk

    The US Food and Drug Administration (FDA) announced it is looking to conduct a study probing how patients perceive risk and come to make decisions, particularly in the context of obese patients seeking medical interventions to reduce their weight. FDA notes in its 18 April Federal Register posting that a whopping 35.5% of men and 35.8% of women in the US are reportedly obese-increasing from 25.7% and 27%, respectively, in 2000. Understanding how this demographic makes...
  • Brazil: New Risk Mitigation Regulation for Devices

    A new regulation ( RDC n o.23 ) published on 9 April 9 2012, requires marketing authorization holders to undertake a series of actions to reduce the risk associated by adverse events related to devices that are marketed in Brazil.  The required actions may involve the effective and timely recall of the product and the need to disseminate public warning messages.  The company must also report to ANVISA the actions it has undertaken, including the assistanc...
  • CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...
  • Report: Increase in Due Diligence Actions Being Driven by Global Legal Trends

    A new report published by PricewaterhouseCoopers (PwC) claims an increase in due diligence activities by regulatory professionals is being driven by a huge increase in global legislation aimed at clamping down on corruption and other shady practices. "Regulators around the world have made it clear that a lack of knowledge about a corrupt act is not a defense; that individual executives will be held criminally liable for the acts of intermediaries; and that hefty fines an...
  • Feature ArticlesFeature Articles

    New Medical Device Standard Puts Healthcare at Risk

    One of the greatest challenges in discussing standards is trying to put things into context so all those affected can understand why they matter. To illustrate this, I want to start with a simple picture- a snapshot of a remarkable moment in time. It shows how small medical device companies can make major contributions to healthcare, and but also how one standard is threatening to undo these gains. [media:1248:embed:{800}:{500}] This photograph was taken in Brazil ...
  • Study: Cancer Trial Leaflets Too Long, Confusing to Patients

    • 28 March 2012
    A study published in the journal Sociology of Health and Illness claims patient information leaflets used to inform patients interested in participating in clinical trials are "too long, incomprehensible, and even intimidating," reports Medical News Today . The study looked at the information sheets of 13 cancer trials, and recruited 26 patients associated with the trials to provide additional feedback on their experiences. "These information sheets are poorly aligne...