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  • Regulatory NewsRegulatory News

    Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight. Background In recent years, FDA has worked to update its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 201...
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    FDA Issues Delayed DSCSA Grandfathering Guidance

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA). While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases ...
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    European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments (20 April 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Reveals Talks With FDA About Joint Accelerated Assessment Activities The European Medicines Agency (EMA) has revealed it is talking to its counterpart in the US about joint activities covering accelerated assessments. The subject is one of several areas in which EMA and the US Food and Drug Administration (FDA) are considering stepping up their cooperation. EMA ha...
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    GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info

    Despite recent steps to improve cybersecurity, the US Government Accountability Office (GAO) said Thursday that the US Food and Drug Administration (FDA) needs to better protect industry and public health data. The report, titled “FDA Needs to Rectify Control Weaknesses That Place Industry and Public Health Data at Risk,” offers 15 recommendations for FDA to fully implement its agency-wide information security program. For fiscal year 2015, the agency said it spent $58...
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    With Weeks Until Drug Track and Trace System Launches, FDA Issues New Guidance

    With just weeks left until new tracking standards come into effect, the US Food and Drug Administration (FDA) is releasing new recommendations it hopes will better secure the pharmaceutical supply chain from accidents and counterfeiters alike. Background In 2013, Congress passed and President Barack Obama signed into law the  Drug Quality and Security Act  ( DQSA ). While the law is perhaps better known for its extensive pharmaceutical compounding reform provisions, it ...
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    Money or Your Life: Report Predicts Ransomware Affecting Medical Devices in Near Future

    European law enforcement authorities are predicting a dark, nefarious future for the cybersecurity of products, including medical devices, which could eventually lead to patients being held hostage from afar. The prediction, made in Europol's 2014 Internet Organized Crime Threat Assessment (iOCTA) , comes amid growing concern about the cybersecurity of devices. In the US, in particular, regulators and researchers have sounded the alarm over the lack of inherent security...
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    FDA Guidance: Federal Efforts to Secure Supply Chain Trump State Efforts

    US regulators have released more information regarding an emerging system intended to prevent counterfeit medicines from reaching US consumers. Background In 2013, Congress passed and President Barack Obama signed into law the Drug Quality and Security Act ( DQSA ). While the law is perhaps better known for its extensive pharmaceutical compounding reform provisions, it also contains another major component formally known as the Drug Supply Chain Security Act (DSCSA) ...
  • Regulatory NewsRegulatory News

    In FDA Effort to Strengthen Regulation of Compounded Drugs, Protections and Profits Intersect

    A new law meant to protect consumers from unsafe pharmaceutical compounding practices is drawing interest from pharmaceutical companies, who are petitioning the US Food and Drug Administration (FDA) to add some of their products to a new list of restricted drugs that could protect patients from deficient drugs—and likely companies from compounded competition as well. Background The Drug Quality and Security Act (DQSA) of 2013 was passed into law in the wake of a massi...
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    FDA Launches New 'Trusted Trader' Import Program With Long List of Incentives

    The US Customs and Border Protection (CBP) and US Food and Drug Administration (FDA) have announced the launch of a new "Trusted Trader" program meant to expedite the import of products made by companies that meet a rigorous selection process. Background FDA and CBP have long sought to make improvements to the process used to import of products, and particularly pharmaceuticals. As explained in numerous Federal Register announcements over the years, the problem ...
  • As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA

    Did legislators go far enough in their attempts to secure the pharmaceutical supply chain when passing the Drug Quality and Security Act (DQSA) last year? That question is now on the minds of some after pharmaceutical manufacturer GlaxoSmithKline issued a massive recall of all lots of its over-the-counter weight loss drug Alli (orlistat capsules) following a determination that some lots of the drug had been " tampered with ." While the DQSA contains extensive requir...
  • FDA Releases Trio of Compounding Guidances Just Days After DQSA Signed into Law

    Just days after President Barack Obama signed the Drug Quality and Security Act ( DQSA ) into law, the US Food and Drug Administration (FDA) has released three draft guidance documents intended to interpret its provisions and provide definitional clarity for compounding pharmacies. Background The DQSA contains two sets of measures: One intended to better secure the pharmaceutical supply chain, and the other to more rigorously regulate the compounding pharmacy se...
  • Track and Trace, Compounding Legislation Passes Senate, Awaits President's Signature

    The Senate, after a series of long delays , has finally passed the Drug Quality and Security Act (DQSA) , all but assuring the law's provisions to institute a national track and trace system and new compounding regulations will be signed into law later this month. Background The  DQSA  was prompted by two issues. The first and perhaps most serious problem has been the lack of a uniform "track and trace" system for pharmaceutical products. While Californi...