• 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...
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    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...
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    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...
  • FDA Releases New Guidance For Industry for Benefit-Risk Evaluations in PMAs, De Novo Classifications

    The US Food and Drug Administration (FDA) released new guidance on 27 March for benefit-risk determinations in premarket approvals (PMAs) and de novo classifications for medical devices. The guidance, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , "is intended to provide greater clarity on FDA's decision making process," FDA wrote. According to the guidance document, "this guidance sets o...
  • FDA Proposes Lowering Risk Classification for Devices Used to Detect Tuberculosis

    The US Food and Drug Administration (FDA) is calling for the reclassification of devices used to detect cases of tuberculosis (TB), lowering the current risk classification in a move that it hopes will streamline the clearance pathway for medical devices. "Currently, these tests are Class III (high-risk) devices that require the more rigorous pre-market approval application," said FDA in a statement released on their website 16 March 2012. FDA is proposing to downclass...
  • New ICH Guideline on Periodic Safety Update Reports

    A new draft guideline put forth by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aims to "be a common standard for periodic benefit-risk evaluation reporting" for products marketed in ICH regions. The draft guidance, entitled E2C(R2): Periodic Benefit-Risk Evaluation Report ,  aims to "ensure that the periodic safety update reports for marketed drugs have the role of being periodic be...