• Regulatory NewsRegulatory News

    Regulators, Experts Outline Plan for New National Medical Device Surveillance System

    Medical devices—and the patients who use them—would substantially benefit from a National Medical Device Postmarket Surveillance System (MDS), charges a new report authored by the Brookings Institution's Engelberg Center for Health Reform with support from the US Food and Drug Administration (FDA). Background The report, Strengthening Patient Care: Building an Effective National Medical Device Surveillance System , comes nearly three years after FDA's Center for ...
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    Report: FDA Drug, Device Approval Times Improving

    A new report issued by the consulting group PricewaterhouseCooper (PWC) indicates that the US Food and Drug Administration (FDA) is making sustained improvements to its drug and medical device approval processes, resulting in new products reaching consumers more quickly. PWC's report, The FDA and industry: A recipe for collaborating in the New Health Economy , is a wide-ranging look at FDA's performance and industry's assessment of its interactions with the regulator....
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    Singapore Regulator Alleges Fake Lab Report Used on Facebook Page

    Singapore’s healthcare product regulator, the Health Sciences Authority (HSA), is alleging that a Malaysian dietary supplement company used falsified lab reports when promoting one of its products on its Facebook page and blog. A Warning on Facebook The company, Champion Club International Sdn Bhd, was warned about the Facebook post by HSA in a 23 December 2014 update on the regulator's website . The update clarifies that the product in question, known as "E250," is ...
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    Report Finds FDA Slow to Approve CNS Drugs, But Getting Faster

    A new report published by the Tufts Center for the Study of Drug Development (CSDD) validates longstanding data indicating that drugs intended to treat disorders of Central Nervous System (CNS) take longer to develop and are rejected by US Food and Drug Administration (FDA) regulators at a higher rate than are other drugs. Background Disorders of the central nervous system are as diverse as they are challenging to treat. Some of the most common CNS disorders include dep...
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    The Case for Sharing Private Drug and Device Data

    A new report published by Georgetown University with support from a US Food and Drug Administration (FDA)-funded project calls for wider sharing of regulatory data in the hopes of enhancing the development of new products. Background The report, Facilitating Medical Product Development Through Voluntary Data Sharing , makes the argument that "wide sharing of research data would be good for scientific discovery and the enterprise of medical product development as well...
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    Federal Audit Finds FDA Website, Internal Network Vulnerable to Hackers

    A government audit of the US Food and Drug Administration (FDA), ordered last year after one of the agency's databases was compromised, has found the agency is vulnerable to hacking attempts which could lead to the loss of sensitive information. Background In November 2013 FDA quietly reported that several databases maintained by its Center for Biologics Evaluation and Research (CBER) had been hacked into. Information on at least 14,000 accounts had been improperly ac...
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    FDA Unveils Policies Meant to Boost Safety, Efficacy of Medical Products for Women, Minorities

    The US Food and Drug Administration (FDA) has released new recommendations on the inclusion of women and other minorities in clinical trials, citing the need to better represent populations which have historically not been adequately included in clinical research. Background When the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was Section 907. The section required FDA to publish a report "addre...
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    FDA Planning Five Guidance Documents to Help Children With Rare Diseases

    • 10 July 2014
    The US Food and Drug Administration (FDA) has released a new report indicating four core ways it plans to accelerate the development of treatments for pediatric rare diseases (PRD). The report, Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases , was required under Section 510 of the Food and Drug Administration Safety and Innovation Act ( FDASIA ) and based off a...
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    New Drug Safety Monitoring Fees Come Into Effect in Europe

    User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week. The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation , is intended to centrali...
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    FDA-Commissioned Report Makes Major Recommendations on How to Improve CDRH

    US medical device regulators should make several major changes to ensure that they are able to regulate products more quickly, efficiently and predictably, a new report commissioned under the Food and Drug Administration Safety and Innovation Act (FDASIA) says. Background The medical device industry has often lambasted the US Food and Drug Administration's review process as being increasingly  onerous, slow and unpredictable —a view also  shared  by government i...
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    Perspectives on the FDASIA Health IT Report and Public Workshop

    On 7 April 2014, a Food and Drug Administration Safety and Innovation Act ( FDASIA )-mandated workgroup issued its strategy and regulatory framework document on health IT to Congress. 1 The workgroup is comprised of representatives from the US Food and Drug Administration (FDA), the Federal Communications Commission (FCC) and the Office of the National Coordinator for Health Information Technology (ONC). A public workshop was held 13–15 May 2014 to discuss the pr...
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    Congress Skeptical About FDA, ONC Effort to Coordinate on Health IT Regulation

    In April of this year, the US Food and Drug Administration (FDA), along with the Office of the National Coordinator for Health Information Technology (ONC), issued a new proposed framework indicating their desire to more consistently regulate health technology, including health software. Now members of Congress have written to the ONC regarding that proposal, saying parts of it go above and beyond its authority under the law. Background In 2012, the  Food and Drug...