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    Medical Device Safety Action Plan: FDA Sets Measure of Success Amid Funding Issues

    The US Food and Drug Administration (FDA) updated its medical device safety action plan on Tuesday with “an important and ambitious new goal” and explained the path forward for its planned nationwide device surveillance system.   The new goal to propel the safety action plan— released in April—is centered around ensuring that the agency is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” FDA...
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    Senators Urge FDA to Clarify Intentions for Digital Health Pre-Cert Program

    With a proposed deadline of 9 November, three US senators sent a letter to the US Food and Drug Administration (FDA) on Wednesday to request more information on the agency’s pre-certification program for digital health.   FDA’s Center for Devices and Radiological Health (CDRH) recently adapted its regulatory processes to the rapidly evolving nature of digital health, while also encouraging questions like those from Sens. Patty Murray (D-WA), Elizabeth Warren (D-MA)...
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    CDRH Looks to Expand Case for Quality Program

    With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end. CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institut...
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    CDRH Works to Develop Proposed De Novo Regulation

    The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019, program lead at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said during a forum at RAPS’ 2018 Regulatory Convergence. The de novo program—established about 20 years ago as a mechanism to evaluate devices that are by statute automatically classified into Class III—saw an anomaly in 2017 prior to its first user fees, noted...
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    CDRH Requests Labeling Changes on Certain Pen Needles

    In a letter to manufacturers of pen needles designed to be used with injectors, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) called for labeling updates to address the adverse events associated with improper patient use.   The request comes after the agency became aware of the reported incidents of hyperglycemia, diabetic ketoacidosis and at least one patient death through medical device reports and FDA’s adverse ev...
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    Special 510(k)s: FDA Seeks Input to Expand Eligibility

    Device manufacturers have two months to help inform US Food and Drug Administration (FDA) draft guidance on its Special 510(k) Program.   The 32-page draft guidance for industry and FDA staff is intended to update the policies set forth when the program was launched in 1998. At the time, modifications to the intended use of a device or any labeling changes were deemed inappropriate for special 510(k) submissions.   “We are proposing to evaluate whether design a...
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    CDER Report on Novel Approvals Highlights Firsts in 2017

    2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties. And though the total 46 approvals is the second-highest number of approvals by CDER ever, according to the CDER ...
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    Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High

    The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of NMEs approved in any year except 1996. But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking NME approvals like a horse race, or compari...
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    FDA Offers Two New Draft Guidances on Developing Targeted Therapies

    The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address underlying genetic mutations that often cause or contribute to diseases, and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from a drug study. "New drugs are being developed based solely on their ability to target these und...
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    What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

    While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence. The creation of this voluntary, alternative 510(k) pathway, first announced back in September , "will allow more flexibility to use more moder...
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    FDA's Frey Reflects on Final Year of PDUFA V

    As the year comes to a close, Patrick Frey, senior advisor to the director of the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), looked back at FDA's performance over the final year of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V) and what's to come in PDUFA VI. Speaking at the FDA/CMS Summit in Washington, D.C. on Tuesday, Frey said that before PDUFA, and during the first four PDUFA programs, FDA was approving ab...
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    EMA Responds to BMJ Article Questioning Benefits of Recent Cancer Drug Approvals

    As more cancer drugs are approved and prices continue to rise, questions have circulated on whether these drugs are extending patient survival or improving quality of life (QoL). A research article published in the BMJ last week reviewed the approval of drugs by the European Medicines Agency (EMA) from 2009 to 2013 and noted that most drugs entered the market without evidence of survival benefits or QoL. "When there were survival gains over existing treatment o...