• Feature ArticlesFeature Articles

    Establishing Effective Device Supplier Qualifications

    Supplier qualification is an important quality system requirement that, when performed effectively, ensures with a high level of confidence that a purchased product will consistently meet specified requirements. An effective supplier qualification procedure should include risk analysis, quality auditing and the use of qualified analytical test methods and statistical techniques to determine supplier capability. A risk score assigned to suppliers, based on the result of s...
  • Bill Proposes National Tracking System for Drug Overdoses

    • 21 August 2012
    The Centers for Disease Control and Prevention (CDC) would be tasked with compiling, analyzing and publishing data on drug overdoses if a new piece of proposed legislation is signed into law. The bill, the Stop Overdose Stat Act (S.O.S. Act) , is more broadly intended to reduce the number of drug overdoses occurring in the US. The bill notes more than 36,000 Americans died from drug overdoses in 2008, with approximately three-in-four of these deaths resulting from a...
  • Feature ArticlesFeature Articles

    Simplify

    "Simplicate, then add lightness."-Colin Chapman, founder of Lotus Cars. I have been a quality professional in the medical device industry for 20 years. During that time, the basic guidance has remained consistent: do not make your quality system procedures too complicated. Even so, I am still surprised at how many professionals try to impress others with complexity. This is almost always a mistake. People are too busy to remember a lot of steps, conditions, exception...
  • DEA to Increase Supply of ADHD, Opioid Ingredients in Light of Shortages

    • 06 July 2012
    The US agency in charge of setting drug production quotas for substances regulated under the Controlled Substances Act (CSA) is proposing a mid-year adjustment in its production quotas for the active pharmaceutical ingredients contained within many attention deficit hyperactive disorder (ADHD) drugs and painkillers in response to growing drug shortages. In a 5 July 2012 Federal Register posting, the US Drug Enforcement Administration (DEA) announced it is looking to ...
  • New Chinese Patent Rules Could Make Country Compulsory Licenser to the World

    Following closely in the footsteps of India , China has announced the release of a new patent system in which it can grant compulsory licenses to generic pharmaceutical manufacturers to allow them to make copies of on-patent branded medicines. Compulsory licenses are used by countries to override patents when a country deems that a health crisis warrants such action. While compulsory licenses have been granted in moderation since the signing of the Doha Declaration ...
  • Study: FDA Recall Communication System Ineffective, Poorly Designed

    It can be difficult to keep up with the dizzying number of drug recall notices sent by the US Food and Drug Administration (FDA). So difficult, in fact, that the agency seems to miss a significant number of recall notices itself, says a new study. The study, published in the Archives of Internal Medicine, finds FDA's recall information communication systems are sorely lacking, failing to disseminate information for as approximately 20% of all recalled medical products ...
  • GHTF Proposes New Harmonization of Medical Device Audits

    The Global Harmonization Task Force ( GHTF ), a medical device-focused regulatory harmonization organization which counts among its members many of the world's top regulatory agencies, announced a new proposed medical device standard aimed at introducing a grading system to be used during regulatory audits by regulatory authorities and auditing organizations. The proposed document, SG3(PD)/N19: Quality Management System - Medical Devices - Nonconformity Grading System ...
  • Woodcock: FDA Time, Resources Now Split Equally Between Premarket, Postmarket Analysis

    Janet Woodcock, Director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), told a meeting of healthcare journalists the agency is heavily invested in tracking postmarketing regulatory issues and has made significant advancements since 2008, reports Reuters . "Our oversight of the safety of marketed drugs has changed significantly over the past few years," said Woodcock in a statement. "This report shows that the quality, acco...
  • As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • Paper Looks to Establish Best Practices for Evaluating Effectiveness of Regulations

    A white paper released by Mini-Sentinel, and adverse event tracking pilot project, evaluates a series of existing studies evaluating the impact of the US Food and Drug Administration's regulatory actions, finding those studies to be largely lacking. The paper, published 12 March and released to the public on 5 April, sought to answer two questions: what regulatory methods have been used by FDA, and what are the best practices for evaluating regulatory actions? The two-p...
  • FDA Makes Changes to Bioresearch Monitoring Information System

    The US Food and Drug Administration (FDA) released new updates to the Bioresearch Monitoring Information System (BMIS) on 9 January.  The program is used by FDA to oversee regulated clinical trials. According to FDA, BMIS "provides controls to ensure that clinical investigators meet the requirements of the relevant statutes and regulations governing FDA-regulated products." This, in turn, supports the bioresearch monitoring (BIMO) program. The changes to BMIS ...
  • Indian Science & Technology Minister Calls for Transparent, Evidence-based Regulatory System

    The head of the Indian Ministry of Science and Technology, Minister Vilasrao Deshmukh, called for a new emphasis on science and technology, including regulatory science, during a speech on 3 January 2011. Speaking at the Indian Science Congress in Bhubaneswar, Odisha, India, Minister Deshmukh said that research and development (R&D) spending should double under a new science and technology policy so that India can catch up to China, according to Biospectrum Asia ...