The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • 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

    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

    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

    Real World Evidence: Can it Support New Indications, Label Expansions?

    At a public workshop in Washington, DC last week, top US Food and Drug Administration (FDA) officials and other experts explored the challenges and opportunities surrounding real world evidence (RWE) in regulatory decision making. The question they sought to answer is whether data gathered from healthcare systems can be used to supplement or support regulatory decisions, such as the approval of new indications or label expansions for existing drugs. FDA currently uses r...
  • Regulatory NewsRegulatory News

    Sentinel, iPod-Based Devices can Match Patients to EHRs in Public Health Emergencies

    A recent study funded by the US Food and Drug Administration (FDA) found that an iPod Touch-based platform and FDA's Sentinel system could be used to accurately track the safety of drugs and vaccines dispensed during public health emergencies. The platform, called the handheld automated notification for drugs and immunizations (HANDI), uses an application running on an iPod touch, fitted with a card reader and barcode scanner, to record patients' information from a drive...
  • Regulatory NewsRegulatory News

    Woodcock: Drug Safety Surveillance System Ready for Full Operation

    The US Food and Drug Administration's (FDA) Sentinel database tracking medical product safety events is now an "integral part of routine safety surveillance," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA said at the 8 th Annual Sentinel Initiative Public Workshop in Washington, DC, Wednesday. "We can, as of today, officially drop 'Mini' from the Sentinel title," she said, noting the progress made since the agency began transition...
  • Regulatory NewsRegulatory News

    Tufts Outlines Regulatory Initiatives to Spur Innovation in 2016

    Further harmonization among major regulatory agencies globally will look to focus on pediatric drug studies in 2016, according to a new report from the Tufts Center for the Study of Drug Development. The report released this week outlines not only what the drug development industry should expect for 2016, but also how regulators will play a major role in keeping drugs safe and in some cases extending marketing exclusivity periods for certain classes of drugs deemed crit...
  • For First Time Since Founding, Government's Mini-Sentinel System Shrinks in Size

    The US government's Mini-Sentinel adverse event active surveillance system had something unusual happen to it this year: It shrank. Background Mini-Sentinel was created in 2008 as an effort to create a nationwide system to track products regulated by FDA after their approval. With the  Food and Drug Administration Amendments Act (FDAAA)  placing a far greater emphasis on post-approval requirements for drugs (instead of requiring all data to be submitted prio...
  • At 160 Million Patients, FDA's Mini-Sentinel Isn't so 'Mini' Anymore

    Despite its name, Mini-Sentinel , the US Food and Drug Administration's (FDA) ambitious attempt at creating an active surveillance system, isn't so miniature. In fact, according to data released by the project this week, it's positively massive. Background Before we dig into those numbers, some background information is in order. Mini-Sentinel was created in 2008 as an effort to create a nationwide system to track products regulated by FDA after their approval. With ...
  • Bill Proposes National Tracking System for Drug Overdoses

    • 21 August 2012
    • By
    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...
  • 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...