• Regulatory NewsRegulatory News

    Congress Eyes Wider Use of Third-Party Medical Device Assessments

    A revised version of the 21st Century Cures Act , a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems. The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act , but was removed without expla...
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    Government Report Slams DEA for Oversight of Drug Production Quota System

    Shortages of some pharmaceutical products could be alleviated if the Drug Enforcement Administration (DEA) coordinated its efforts to control the supply of some drugs more closely with the US Food and Drug Administration (FDA), a new government report has found. Background In the US, drug products are primarily overseen by two federal agencies: FDA and DEA. The former regulates drugs in accordance with their efficacy, safety and quality. For example, FDA might approve a...
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    DEA to Increase Marijuana Production Quota to Meet Demand of Medical Researchers

    The US Drug Enforcement Administration (DEA) is proposing to more than triple the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced. Background In the US, the manufacture and production of marijuana is controlled by the DEA, whose authority to do so stems from the Controlled Substances Act (CSA) —a law which categorizes drugs in accordance with their ri...
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    Regulators, Experts Outline Plan for New National Medical Device Surveillance System

    Medical devices—and the patients who use them—would substantially benefit from a National Medical Device Postmarket Surveillance System (MDS), charges a new report authored by the Brookings Institution's Engelberg Center for Health Reform with support from the US Food and Drug Administration (FDA). Background The report, Strengthening Patient Care: Building an Effective National Medical Device Surveillance System , comes nearly three years after FDA's Center for ...
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    British Regulators Launching Online Registration System for Low-Risk Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on 11 February 2015. The new  Devices Online Registration System (DORS)  will facilitate online registration of Class I devices, as well as cu...
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    FDA, CDC Preparing Updated Form to Record Vaccination Problems

    The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form. Background In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form. VAERS is used by FDA and CDC, which co-administer th...
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    US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola

    Legislators in the US Senate have unveiled a new piece of legislation meant to incentivize companies to go after the Ebola virus by making critical and long-sought changes to a US Food and Drug Administration (FDA) regulatory program. Background As Focus explained in October 2014 , a recent outbreak of Ebola has led to a scramble for new drugs and vaccines to help treat and prevent the virus. At present, there are no recognized treatments for the disease. Some publi...
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    Report Finds FDA Slow to Approve CNS Drugs, But Getting Faster

    A new report published by the Tufts Center for the Study of Drug Development (CSDD) validates longstanding data indicating that drugs intended to treat disorders of Central Nervous System (CNS) take longer to develop and are rejected by US Food and Drug Administration (FDA) regulators at a higher rate than are other drugs. Background Disorders of the central nervous system are as diverse as they are challenging to treat. Some of the most common CNS disorders include dep...
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    Brazilian Regulator Anvisa Issues New Track and Trace Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, has published guidance on the implementation of the country's track and trace system for drugs, the National Drug Control System (SNCM).  The guidance manual , released 18 August 2014, specifies the requirements for mandator...
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    Public Comment Period Opens on ISO 9001, Major Device Quality Standard

    The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation. Background The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The ISO 9001 standard is used extensively throughout the medical...
  • Feature ArticlesFeature Articles

    Creating a Culture of Compliance

    In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis. This focus creates a culture that views compliance as a positive, critically important part of the business. In fact, a recent study sho...
  • UK’s MHRA Proposes Tracking System for High Risk Devices

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced that four National Health Service hospitals have agreed to pilot a new tracking system for high risk medical devices.  The goal of the tracking system, one of 11 projects established by the agency in response to the Poly Implant Prothèse silicone breast implant issue, is to improve the monitoring of medical devices such as breast implants, heart valves and pacemakers. The new...