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MDUFA talks expose 'fundamentally different' views of FDA and device companies

MDUFA talks expose 'fundamentally different' views of FDA and device companies
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FDA Suspends Review for Non-COVID-19 In Vitro Diagnostics (IVD) Submissions and Expects Review Delays in Non-IVD Products | Womble Bond Dickinson

[author: Heather Hatcher, Ph.D.]
A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.” Dr. Jeff Shuren, Director, CDRH, and Dr. William Maisel, Director, Office of Product Evaluation and Quality at CDRH, reported that the astounding numbers of pre-EUA and EUA submissions received for COVID-19 tests and collection kits created a significant workload that has strained the center’s resources in the review of in vitro diagnostic (IVD) files. Shuren and Maisel report that current pre-EUA and EUA submissions under active review across the center exceeds 600 with an average receipt of more than 40 new pre-EUA and EUA submissions per week in addition to non-COVID-related submissions. Every office in CDRH has been hea ....

William Maisel , Jeff Shuren , Office Of Product Evaluation , Radiological Health , Product Evaluation , Medical Device User Fee Amendments , வில்லியம் மைசேல் , அலுவலகம் ஆஃப் ப்ராடக்ட் மதிப்பீடு , கதிரியக்கவியல் ஆரோக்கியம் , ப்ராடக்ட் மதிப்பீடு , மருத்துவ சாதனம் பயனர் கட்டணம் திருத்தங்கள் ,

Review for Non-COVID-19 In Vitro Diagnostics Suspended

Review for Non-COVID-19 In Vitro Diagnostics Suspended
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William Maisel , Jeff Shuren , Office Of Product Evaluation , Radiological Health , Product Evaluation , Medical Device User Fee Amendments , வில்லியம் மைசேல் , அலுவலகம் ஆஃப் ப்ராடக்ட் மதிப்பீடு , கதிரியக்கவியல் ஆரோக்கியம் , ப்ராடக்ட் மதிப்பீடு , மருத்துவ சாதனம் பயனர் கட்டணம் திருத்தங்கள் ,

Timeline for J&J's vaccine pause grows murkier

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With Lauren Morello and Sarah Owermohle.
On Tap
U.S. is now sequencing six percent of Covid-19 cases.
FDA rebuts Trump-era proposal to deregulate review of many medical devices.
It’s Friday, welcome back to Prescription Pulse. Your author is getting his first Covid-19 vaccine shot today! As always, send tips to David Lim ([email protected] or @davidalim). ....

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Real world evidence backs up vax trials

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On Tap
Covid-19 vaccines appear to be nearly as effective in the real world as in trials, a pre-print study suggests.
Biden admin plots an expansion of Covid-19 testing.
FDA, USDA leaders say there is no evidence Covid-19 has been transmitted by food or food packaging. ....

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