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    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...
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    Report Outlines New FDA Device Evaluation System, Coordinating Center

    A national medical device evaluation system planning board, created in part by the US Food and Drug Administration (FDA), released a new report on Monday outlining how it plans to develop such a system and a center to coordinate such efforts. Both the national medical device evaluation system (NMDES) and the coordinating center are part of a larger goal of FDA’s to expedite the generation and dissemination of reliable medical device data, including real-world evidence, i...
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    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...
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    FDA Reaffirms Endoscope Washer Recall After Company Tries to Correct Devices

    The US Food and Drug Administration (FDA) has reiterated its recall of Custom Ultrasonics' automated endoscope reprocessors (AERs) after the company had proposed to correct, rather than recall the AERs, which FDA rejected as the devices fail to adequately wash and disinfect endoscopes. Duodenoscopes Duodenoscopes are a type of endoscope manufactured and sold in the US by Fujifilm, Pentax and Olympus and are notoriously difficult to clean. Customs Ultrasonics AERs, whic...
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    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...
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    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...
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    CDRH Bans Imports From Australian Company for Failing to Meet Quality System Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) added Australia’s TFS Manufacturing to a list of medical device manufacturers that have not met device quality system requirements. TFS says it manufactures a tissue fixation system that “repairs organ prolapse by tensioning the ligaments and bringing laterally displaced connective tissue structures, such as ligaments and fascia, together. It combines soft tissue anchors with ...
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    Device Industry Calls for Clarifications to Draft Animal Studies Guidance

    The Advanced Medical Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices. Draft Guidance FDA released the draft guidance, General Considerations for Animal Studies , for public comment in October 2015. The guidance is intended to assist industry in designing, conducting and reporting data from animal studies used to de...
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    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...
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    CDRH Increases Foreign Quality System Inspections

    Although the number of quality system surveillance inspections only rose slightly between 2013 and 2014 overall, the number of such inspections for foreign manufacturers increased by nearly 30%, according to new data released by the FDA’s Center for Devices and Radiological Health (CDRH). CDRH said the new numbers show that the agency, which previously upped its inspections of foreign generic drug manufacturers , has been working to increase inspections in foreign count...
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    Medical Device Audit Program Needs More Industry Involvement, Report Says

    A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says. Background Back in January 2014, the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force, launched a two-year pilot program ...
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    India Unveils New Online Submission System for Clinical Trials

    India's Central Drugs Standards Control Organization (CDSCO) has launched a new online submission system for clinical trials as part of efforts to increase transparency, accountability and efficiency in processing trial applications. CDSCO says the new online system will help in the collection and organization of information on sponsors, contract research organizations, investigators, ethics committees and trial subjects. The release of the submission system comes as...