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Tag Archives: CDRH
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 eCTD, Industry News
Tagged advisory committees, CDRH, FDA, medical devices, transparency
1 Comment
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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