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FDA CDRH Portal Now Offers Tracking of Pre-Submissions On May 22, the FDA announced that it has updated the CDRH Portal to allow users to track the progress of Pre-Submissions. A submitter must specify the type of Pre-Submission request, which include: written feedback (only) written feedback followed by a meeting The agency noted that the …
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Selecting a Resilient Medical Device Contract Manufacturer for Long-term Success Finding a resilient medical device contract manufacturer (CM) ensures a consistent supply chain, regulatory compliance, and long-term business success. Whether you are a Fortune 500 company or an early-stage startup, you will benefit from taking the time to find a CM partner who can …
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Three Steps to Gain the Full Advantage of Pharmaceutical Business Forecasting Business strategy and forecasting influence several functional areas within an organization. These relationships may be in one direction (where forecasts feed into decisions made by the other functional areas) or in many directions (where the forecast is used to generate changes proposed by …
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Clock Starts for New EU MDR Transition Dates An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European Union on March 20. Producers of medical devices will now have until December 31, 2027, for …
Chin Named Chief Financial Officer of Akido Eric Chin is the new Chief Financial Officer of Akido, a tech-integrated medical network. Chin previously served as Chief Financial Officer at Apollo Medical Holdings, a publicly traded physician-centric technology-powered healthcare company. During Chin’s time at ApolloMed, the company was a member of the S&P SmallCap 600. …
Cleeland Joins Francis Medical Board of Directors Andrew Cleeland, CEO of Fogarty Innovations, has joined the Francis Medical Board of Directors. Francis Medical is a privately held medical device company developing a proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer. Prior to joining Fogarty Innovations, Cleeland served as …
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Lace To Helm New RQM+ Reimbursement Division RQM+, a global MedTech regulatory and quality service provider, has launched a reimbursement division to provide its clients with reimbursement services, in addition to regulatory, quality, clinical and laboratory services, throughout the medical device and diagnostics product lifecycle. Daniel Lace, MD, will lead the new division and …
CDRH Launches Pilot Program To Reduce Device Approval Times The FDA Center for Devices and Radiological Health (CDRH) is launching the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. “TAP is a voluntary program intended to de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with …
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American Health Care Has a Diagnostics Problem As everyone knows, America has among the world’s highest healthcare costs, spending $4.1 trillion per year—about $12,500 per person, or three times the OECD average. But another aspect of our health system gets far less attention: our focus on reactive treatment instead of proactive diagnostic and preventive …
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