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  • Regulatory NewsRegulatory News

    FDA Finalizes Buprenorphine Drug Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing new types of buprenorphine depot products for medication assisted treatment (MAT) for opioid use disorder amid the ongoing opioid epidemic.   Buprenorphine, along with methodone and naltrexone, are the only drugs approved by FDA to treat opioid use disorder.   Buprenorphine MAT works by reducing patients’ withdrawal symptoms and blocking the euphoric effects of other opioid drug...
  • Regulatory NewsRegulatory News

    Opioids: GAO Calls on HHS to Assess Effectiveness of Expanding Medication-Assisted Treatment

    The Government Accountability Office on Tuesday issued a report calling on the US Department of Health and Human Services (HHS) to assess the effectiveness of efforts to expand the use of medication-assisted treatment (MAT) for opioid addiction. The report follows a House hearing last week in which FDA Commissioner Scott Gottlieb announced several steps the agency will take to promote the development and use of MAT. Background The report and Gottlieb's testim...
  • Regulatory NewsRegulatory News

    Gottlieb: Next Steps in Opioid Crisis May be 'Uncomfortable'

    In testimony before the House Energy & Commerce Committee on Wednesday, FDA Commissioner Scott Gottlieb said that the next steps in efforts to combat the ongoing opioid crisis will be difficult, but necessary given the spread of the epidemic. "We'll need to touch clinical practice in ways that may make some parties uncomfortable," Gottlieb said, pointing to restrictions on prescribing and mandatory education for physicians as possible steps. "Long ago we ran out of stra...
  • Feature ArticlesFeature Articles

    Mistake-Proofing the Workplace

    This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors. Introduction On his first job working for a large pharmaceutical company, one of the authors, Max Sherman, was responsible for th...
  • Regulatory NewsRegulatory News

    FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

    Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion. The new administration’s impact on FDA was not discussed, though some officials discussed how FDA is moving forward with initiatives begun under President Barack Obama’s administration. Elizabe...
  • Regulatory NewsRegulatory News

    ICH Working Group to Provide More Detailed Guidance

    The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues. According to a new concept paper endorsed by the ICH MedDRA (Medical Dictionary for Regulatory Activities) Management Board in November 2016, topics that ...
  • Regulatory NewsRegulatory News

    Confusion Pushes FDA to Change Antidepressant’s Brand Name

    The US Food and Drug Administration (FDA) on Monday approved a brand name change for Takeda’s antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from confusion with AstraZeneca’s blood-thinning medicine Brilinta (ticagrelor). The new brand name of Brintellix will be Trintellix, and the tablets will look nearly identical and are expected to be available in June, FDA said. “No other changes will be made to the la...
  • Regulatory NewsRegulatory News

    Final FDA Guidance on Drug Design Seeks to Reduce Medication Errors

    The US Food and Drug Administration has finalized guidance detailing best practices on how to improve a drug's container closure system to minimize the risk of medication errors. Medical errors, which include medication errors, are one of the leading causes of preventable death in the US. A report published by the Institute of Medicine (IOM) in 1999 found that between 44,000 and 98,000 Americans die each year due to medical errors, though other estimates place that figur...
  • 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...