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Tag Archives: CDRH
CDRH Proposes Changes to the 510(k) Pathway
All for one, one for all, that is our device. – Alexandre Dumas The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, FDA, guidance, medical devices
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Use A Detailed Development Plan to Secure Venture Capital
This is a guest post by Shane Grivna, Ph.D. Shane is a Clinical Strategy Scientist for Cato Research and an Analyst for Cato BioVentures. It’s a tough time to be asking for money. Whether you’re a highschooler who needs cash … Continue reading
Posted in Guest Posts, Venture Capital
Tagged biologics, business plan, Cato BioVentures, CDRH, development plan, drug development, FDA, venture capital
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Device Advisory Committee Changes
If you don’t like how things are, change it! You’re not a tree. – Jim Rohn Planning on attending an Advisory Committee meeting for a medical device in the near future? If you’re a regular at them, you may soon … Continue reading
Posted in Industry News, eCTD
Tagged advisory committees, CDRH, FDA, medical devices, transparency
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FDA-TRACK – The FDA’s FDA-Tracking System
Data is what distinguishes the dilettante from the artist. – George V. Higgins In another move on its transparency initiative, the FDA has recently announced a new program to publicly track its own performance. It’s called FDA-TRACK and, in the … Continue reading
Posted in FDA, Industry News
Tagged BLA, CBER, CDER, CDRH, FDA, FDA-TRACK, IND, NDA, postmarketing, transparency
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