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  • Regulatory NewsRegulatory News

    CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices

    The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) launched a new voluntary 510(k) pilot program to develop and refine individual premarket testing recommendations for ophthalmic optical coherence tomography (OCT) devices.   Under the pilot program, the individual premarket testing recommendations CDRH staff will seek to refine in collaboration with participating manufacturers are aimed at enabling greater consistency in 510(k) s...
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    Cybersecurity: FDA Spells Out Updated Premarket Policies

    With its first guidance in the device space in FY 2019, the US Food and Drug Administration (FDA) unveiled an awaited draft guidance on Wednesday to clarify the agency’s cybersecurity expectations from a premarket perspective. The draft guidance is an update to 2014 premarket policies on cybersecurity and came as the ink was still wet on the memorandum of agreement (MOA) between FDA and the US Department of Homeland Security (DHS) for strengthening a coordinated approac...
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    Medical Device Validation: What You Need to Know and Why It's Important

    Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...
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    Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

    The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies. The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications ...
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    FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin

    The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s blockbuster breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India. First approved in the US in 1998, Herceptin had US sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVI...
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    FDA Expands Generic Drug Priority Reviews

    Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue. The progress comes as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday indicated that the agency will expand which abbreviated new drug applications (ANDA) will see priority reviews. "Earlier this year we made changes to how we pri...
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    Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Opens Door to Foreign Clinical Trial Data to Accelerate Drug Approvals China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients. The State Council broke its proposals up i...
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    European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Pilots Changes to Accelerate Drug Authorizations The Swiss Agency for Therapeutic Products (Swissmedic) has begun pilot testing changes intended to speed up the drug authorization process. Swissmedic identified revisions to the labeling phase of the process as potentially having the most impact on authorization times by analyzing results from a four-year be...
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    IMDRF Consults on Use of Registries to Support Device Approval Decisions

    The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making. Background Registries, which can capture outcomes associated with medical device use, were identified by IMDRF in 2014 as having "a significant gap" in optimal use for regulatory decision making. This gap led to the creation of IMDRF Registry Working Group ...
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    Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

    The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found a higher association with these expedited pathways and the likelihood of safety-related labeling changes than with non-expedited pathways. In their analysis of 15 years of data, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Program on Regulation, Therapeutics, And Law...
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    FDA Approves 6th Biosimilar in US, Second for Humira

    The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab). Cyltezo, which follows the approval of Amgen's Amjevita (adalimumab-atto) last September , has been approved for multiple indications (see link to label below), did not go before an FDA advisory committee and was not approved as an interchangeable biosimilar. How...
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    Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market

    Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks and clinical trial designs of new drugs and medical devices sped to market without enough preliminary evidence that they are effective. In one of the articles, which evaluated the use of FDA’s accelerated approval pathway, questions were raised on the use of surrogate measures as outc...