• Regulatory NewsRegulatory News

    FDA Accepts for Review First NDA for a 'Digital' Medicine

    The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet. The developer of the sensor – Proteus Digital Health – said it could help improve patient medication adherence and better inform physician decision-making to tailor treatments to the patient's needs. In the case of this new drug application, the sensor is paired with Otsuka...
  • Regulatory NewsRegulatory News

    FDA: Brand Name Confusion Led to Dozens of Medication Errors

    The US Food and Drug Administration (FDA) has issued a safety alert for two drugs, Brintellix and Brilinta, after receiving 50 reports of confusion between them caused by similarities in the drugs' names. Background When a new drug is submitted to FDA for review, the agency's Division of Medication Error Prevention conducts a review of the product's proposed brand name. FDA's main concern in reviewing the brand names of drugs is to ensure that a drug's brand name does n...
  • Regulatory NewsRegulatory News

    Plain Language Labeling Regulations to Take Effect in Canada

    Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015. Background In 2013, Canada's then-Minister of Health Leona Aglukkaq announced the government was launching a new initiative toimprove drug safety by making product information easier to understand for consumers. Making labels and packaging easier to understand, Aglukkaq said, would "help prevent advers...
  • Regulatory NewsRegulatory News

    EMA Releases Draft Guides to Reduce and Report Medication Errors

    To address the risk of medication errors, the European Medicines Agency (EMA) has released two new draft documents intended to guide regulators and industry in reporting, evaluating and preventing medication errors. Medication errors are mistakes made when prescribing, dispensing and administering medicine. The agency says these errors are the "most common preventable cause of undesired harmful effects" related to medicine in the EU. According to EMA, these errors have...
  • Feature ArticlesFeature Articles

    Leprosy––Not Yet Consigned to History

    The word leprosy brings to mind a gruesome disease that separates its sufferers from society and continues to strike fear into communities, much like Ebola. While the genome for leprosy has been sequenced and there is a drug cocktail that effectively cures the disease, its mode of transmission still is unknown. A disease that dates back through millennia, leprosy so far has eluded efforts to find the final piece of information that might eradicate it from the world per...
  • US Regulators Look to Continue, Expand Support for Medication Adherence Campaign

    The US Food and Drug Administration (FDA) plans to continue providing funding to a campaign first started in 2010 to promote the importance of medication adherence to overall health-a potential boon to companies which have long argued that improper adherence can cause adverse events, result in worse outcomes for patients, cost government programs money and harm their revenues. FDA seemed to back those contentions in its 5 June 2013 Federal Register notice, explaining t...
  • EU Regulators Identify Methods of Reducing Medication Errors, Seek Path Forward

    EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication errors. That workshop , held in February 2013, brought together regulators across the EU in the hopes of raising awareness around new legal requirements for reporting medication errors and to generate best practices for EU regional regulators. Those errors, as defined by the a...
  • FDA Issues New Drug Labeling Recommendations Intended to Avoid Medication Errors

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry recommending changes to the way companies place safety information on container labels and cartons, saying the changes are intended to reduce the number of medication errors. Background A 2006 report by the US' Institute of Medicine (IOM), a government think tank of sorts focused on healthcare, found that a major source of medication errors could be attributed to product labeling. ...
  • New Emphasis on Reducing Medication Errors to Have Regulatory Implications, Says EMA

    The European Medicines Agency (EMA) is looking to reduce the number of medication errors that take place in the EU through the formation of a new coordinated approach that could ultimately have regulatory implications, the agency announced. The proposal, which came out of an EMA workshop held for two days starting 28 February 2013, would specifically seek to improve the reporting of medication errors in the hopes that additional data could prove useful in preventing futu...
  • New Guidance Aims to Reduce Medication Errors Through Better Preapproval Testing

    The US Food and Drug Administration (FDA) has published a new draft guidance on ways to minimize medication errors through designing products with safety considerations in mind, part of the agency's unfinished efforts under the FDA Amendments Act (FDAAA) of 2007. The guidance , posted to FDA's website on 12 December 2012, notes that it is intended to provide sponsors of pharmaceutical and biopharmaceutical products with "a set of principles for developing drug product...
  • Overestimated Efficacy, Underestimated Risks Guide Patient Treatment Options

    • 13 November 2012
    Patients and physicians alike often have lofty expectations and aspirations about the effectiveness of a prospective treatment. But, as a new article in the Annals of Family Medicine argues, those expectations contribute significantly to both the increasing costs of healthcare and avoidable harms suffered by patients. At the core of the healthcare cost crisis right now is an unavoidable fact, writes Steven Woolf, MD: The cost of obtaining healthcare, and in particular ...
  • FDA Releases Adverse Event Guidance for Small Businesses

    The US Food and Drug Administration (FDA) wants to help small businesses comply with regulations pertaining to adverse event reporting. In 2008, the agency released a new regulation directing all companies to include a hotline number for FDA's adverse event reporting service, which collects information about safety issues. The number must coincide with an explanation of what the number is, and that it is not intended for dispensing medical advice. In its 14 June guidanc...