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  • Regulatory NewsRegulatory News

    Q&A: A New Society Targets Digital Medicine Alongside FDA Officials

    The Massachusetts-based Digital Medicine Society (DiMe) launched this week with a strategic advisory board that includes Amazon, as well as top drugmakers like Novartis, and a scientific leadership board including US Food and Drug Administration (FDA) officials. Among the FDA officials on its scientific leadership board are Bakul Patel, digital health director at FDA’s Center for Devices and Radiological Health (CDRH), CDRH’s lead of cybersecurity initiatives, Suzanne S...
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    BD’s CareFusion Agrees to $3.3M DOJ Settlement Over Unapproved Devices

    CareFusion, a subsidiary of Becton Dickinson (BD), agreed to a $3.3 million settlement to resolve allegations of civil fraud under the False Claims Act over purchases and sales of unapproved devices. The case was brought on by the US Department of Justice (DOJ) and alleged that providers who used CareFusion devices in medical procedures submitted false claims to federal insurance programs, such as Medicare. The devices allegedly lacked US Food and Drug Administration ...
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    FDA Unveils 34 New and Revised Product-Specific Draft Guidances

    The US Food and Drug Administration (FDA) on Wednesday released its latest batch of product-specific guidance documents to support the development of generic drugs, with 25 new and nine revised draft guidances. HIV antiretrovirals and antibiotics topped the list of new draft guidances with a total of five, followed by drug products containing active ingredients to treat ophthalmic ailments and cancers. Among the revised product-specific drafts is one for azelaic acid an...
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    Repeat GMP Violations Spur FDA to Ban Canadian OTC Drugmaker Imports

    A US Food and Drug Administration (FDA) inspection at a Canada-based over-the-counter (OTC) drug manufacturing facility revealed violations of good manufacturing practices (GMP)—similar to those cited in 2012 and 2014. A new FDA warning letter cites Petra Hygienic Systems International for four violations of GMP regulations for finished pharmaceuticals, following the site inspection FDA conducted last December. Imports from the firm have been blocked from entering the U...
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    FDA’s Proposal to Limit Device Predicates Fails to Garner Industry Support

    The medical device industry is criticizing a US Food and Drug Administration (FDA) proposal to limit the use of older predicate devices, citing misconceptions about the 510(k) pathway, hindered market access, stifled innovation and competition and more regulatory burdens. The comments on the November 2018 proposal argue that a limit on manufacturers’ use of predicates would be a setback from improvements made to the program since its 1976 enactment. The 510(k) path...
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    Updated: Murray Questions Devicemakers on Contaminated Duodenoscopes

    With a 23 May deadline to reply, Sen. Patty Murray (D-WA) sent duodenoscope makers a letter to request information regarding the high rates of contamination previously linked to using some of their duodenoscopes. “I am writing today to understand how your company plans to respond to these troubling findings and what changes may be necessary going forward to ensure patient safety,” Murray said. She referred to the preliminary results of the postmarket surveillance studie...
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    Health Canada Drafts Policies for Special Access to Medicines Program

    Similar to the US Food and Drug Administration’s expanded access program, which allows for those with serious or life-threatening conditions to gain access to experimental medicines, Health Canada opened a draft guidance consultation on changes to its Special Access Program (SAP) for drugs. The 29-page draft guidance builds on previous guidance adopted in 2014 and explains how Canadian health care practitioners can obtain access to an unauthorized drug for emergency t...
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    FDA Warns of Battery Depletion in Medtronic Pacemakers

    Manufacturing defects continue to cause distress for Medtronic, with a new US Food and Drug Administration (FDA) safety communication warning of premature battery depletion in pacemakers. The agency’s safety notice alerted about an issue with device capacitors, which led to rapid battery depletion in certain Medtronic implantable pacemaker models. It indicated FDA’s awareness of three adverse event reports linked to this issue—one of which resulted in the death. “In ...
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    Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews

    US Food and Drug Administration (FDA) draft guidance on combination products’ premarket review principles needs further clarity on a range of issues, according to commenters. The public comment period on the February draft guidance —a document tasked with implementing goals set forth under section 3038 of the 21 st Century Cures Act of 2016 —closed earlier this week. Commenters show appreciation for FDA’s efforts to serve such goals of greater “clarity, predictab...
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    Industry Works to Circumvent EU MDR/IVDR ‘Horror Story’

    Transitioning to the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) have left industry with no choice but to resort to contingency planning, including an IVDR “plan B.” From the looming shortfall of notified bodies (NBs) to the ongoing lack of MDR/IVDR guidance, 2019 FDA/Xavier MedCon conference sessions underscored daunting realities related to the regulatory overhaul. NBs, manufacturers and regulatory authorities have come increasingly under pres...
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    CDRH Remains Bullish on 510(k) Modernization

    At the 2019 FDA/Xavier MedCon conference in Cincinnati this week, modernizing the 510(k) program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) was called into question because of limited industry use of the new or expanded 510(k) programs. But CDRH officials remained steadfast in their plans. Industry struggled to keep pace with the rapidly evolving 510(k) landscape, with 510(k) modernization initiatives launched in the pas...
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    FDA’s Device Inspections Program Sets FY19 Performance Goals

    New performance goals for the Office of Medical Device and Radiological Health Operations (OMDRHO) at the US Food and Drug Administration (FDA) were set on FDA’s and industry’s follow-up to inspections. The performance goals for fiscal year (FY) 2019 are intended to tell the story behind inspection metrics in terms of the public health impact, OMDRHO Director Jan Welch said at the 2019 FDA/Xavier MedCon conference in Cincinnati. Welch, who took the helm at OMDRHO with t...