• Feature ArticlesFeature Articles

    RWD, RWE, and improved patient outcomes: From FDA's Mini-Sentinel to real-world examples

    Uses of real-world data and evidence (RWD and RWE) have proliferated in recent years, driven by advances in data-gathering tools and methods and enhanced understanding of the value of such data and evidence. Under the 21st Century Cures Act of 2016, Congress codified RWD and RWE in the drug development and approval process. There are many opportunities for the use of RWD and RWE in the approval, labeling, clinical use, and marketing of medical products to enhance individu...
  • OSE's annual report details Sentinel efforts during COVID pandemic

    The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.   The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health emergency of the COVID-19 pandemic, noted Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology (OSE).   However, OSE also continued its efforts in other a...
  • Regulatory NewsRegulatory News

    HHS moves to end FDA’s unapproved drugs initiative

    Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to increased drug prices for some older drugs. FDA’s unapproved drugs initiative can be traced back more than a decade to the agency’s 2006 compliance policy guide (CPG) on marketed drugs without approved new drug applications (NDAs...
  • Regulatory NewsRegulatory News

    New MAPP details when FDA notifies drugmakers about ARIA studies

    In a new manual of policies and procedures (MAPP) released on Monday, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) explains how and when it will notify applicants when the agency plans to study a product using its Sentinel active risk identification and analysis (ARIA) system.   Before FDA can require a postmarketing study or clinical trial for a drug, it must determine whether its ARIA system or adverse event reporting sys...
  • Regulatory NewsRegulatory News

    Sentinel: FDA Outlines Five-Year Roadmap

    As the US Food and Drug Administration's (FDA) Sentinel Initiative approaches its 11 th anniversary, the agency on Wednesday laid out its vision for enhancing the system over the next five years.   First launched as a pilot program in 2008, the Sentinel Initiative encompasses FDA’s effort to meet obligations set by Congress in the 2007 Food and Drug Administration Amendments Act to develop a system for active postmarket risk identification and analysis for medical p...
  • Regulatory NewsRegulatory News

    Study Finds FDA Action on Unapproved Drugs Led to Higher Prices, Longer Shortages

    A new study finds that the US Food and Drug Administration's (FDA) 2006 initiative to get manufacturers selling unapproved drugs to submit the drugs for approval or remove them from the market led to higher prices and longer shortages for those drugs. Background Today, drugs must be reviewed by FDA for safety and efficacy or in some cases conform to an over-the-counter (OTC) monograph before they can be marketed in the US. However, in the years between the 1938 Food, D...
  • Regulatory NewsRegulatory News

    CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics

    The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children. According to CTTI, a public-private partnership aimed at improving the quality and efficacy of clinical trials, challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations. Furthermore, ...
  • Regulatory NewsRegulatory News

    PDUFA VI: Highlights on What to Expect

    The US Food and Drug Administration (FDA) and stakeholders from industry and patient groups on Monday outlined the agreement they forged on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) that begins in 2017, focusing on what’s to come on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development. The meeting follows the July release of the full details of the performance ...
  • Regulatory NewsRegulatory News

    FDA Commissioner Calls for Better National System to Track Device Safety

    The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA . The call for better postmarket tracking of devices comes as professional societies have developed registries with details on clinical circumstances, procedures and outco...
  • Regulatory NewsRegulatory News

    Two Draft FDA Guidelines on NGS Set Foundation for Precision Medicine Initiative

    New next generation sequencing (NGS) technologies that can examine millions of DNA variants at a time and help inform treatment decisions are at the heart of two new draft guidance documents released Wednesday evening by the US Food and Drug Administration (FDA) as part of President Barack Obama’s Precision Medicine Initiative. FDA says the guidance offers a streamlined approach to the oversight of diagnostics that detect medically important differences in a person’s gen...
  • Regulatory NewsRegulatory News

    Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA

    The "top programmatic priority" for the US Food and Drug Administration (FDA), under Commissioner Robert Califf, is to leverage real world evidence from the healthcare system to inform FDA decision making, he told participants at the Food and Drug Law Institute's annual conference last week. While Califf said his first priority as commissioner is to strengthen FDA's workforce, that stronger workforce will be critical to achieving FDA's goals in specific program areas s...
  • Regulatory NewsRegulatory News

    Precision Medicine: Technology, Regulations and Challenges

    • 11 March 2016
    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...