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  • Regulatory NewsRegulatory News

    EHR Data in Clinical Trials: New FDA Draft Guidance

    The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations. The 12-page guidance is meant to facilitate the use of EHR data in clinical trials and “promote the interoperability of EHRs and electronic systems supporting such trials.” Prepa...
  • 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...
  • US Health IT Officials Call for Integration of FDA's Unique Device Identification with eHealth Records

    The Office of the National Coordinator (ONC), a US health technology implementation advocate, has announced a new proposed rule that would advocate for the integration of the US Food and Drug Administration's (FDA) recent Unique Device Identification (UDI) rule with electronic health records (EHRs). Background A  UDI  is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulator...
  • FDA Wants to Leverage Electronic Medical Records to Probe for Adverse Events

    Keeping track of adverse events is a tricky task, even for regulators. Even when a drug has undergone a rigorous premarket assessment process, some risks may not become evident until a product is used by millions. And for other drugs, a particularly rare but serious side effect may take months, if not years, to be identified. But being a regulator in 2014 means having access to something regulators of old did not: Big data. In late December 2013, the US Food and Drug Ad...
  • FDA, Data Standard Groups Promote Adoption of EHRs

    The US Food and Drug Administration (FDA), the US Department of Health and Human Services' (DHHS) Office of the National Coordinator for Health Technology (ONC) and the Clinical Data Interchange Standards Consortium (CDISC) have together issued a call for greater use of electronic health records (EHR) in clinical research. In a 6 August statement, CDISC, a nonprofit devoted to clinical regulatory standards, said the agencies' challenge involved the, "Use at least two d...
  • Woodcock: Electronic Health Records Key To Helping Regulatory Professionals

    Janet Woodcock, Director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), told a pharmaceutical conference this week that electronic health records are key to allowing regulators to "learn more quickly of problems with medicines after they enter the market," reports The Philadelphia Inquirer . Woodcock noted the numerous issues with the current system of prescribing and tracking pharmaceutical products and their adverse even...