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Tag Archives: CDER
Bookmarks – Collapsed or Expanded?
At Cato Research, part of our standard document preparation work for eCTD submission documents is to save every PDF file with the bookmarks collapsed (i.e. only the top level bookmark is visible when the document is opened). We’re often asked … Continue reading
An FDA Perspective on Risk/Benefit
If a man is alive, there is always danger that he may die, though the danger must be allowed to be less in proportion as he is dead-and-alive to begin with. A man sits as many risks as he runs. … Continue reading
FDA Forms Biosimilar Work Group
In the end we are all separate: our stories, no matter how similar, come to a fork and diverge. We are drawn to each other because of our similarities, but it is our differences we must learn to respect. – … Continue reading
Posted in FDA, Industry News
Tagged biologics, biosimilar, CBER, CDER, FDA, Janet Woodcock
1 Comment
DDMAC Sends Warning Letter Over Unbranded Websites
If you judge, investigate. – Seneca I know you just read the title, but let me say it again with some emphasis: DDMAC Sends Warning Letter Over Unbranded Websites. That’s right, a warning letter over websites that contained no “direct” … Continue reading
Posted in FDA, Industry News
Tagged 21 CFR, accelerated approval, advertising, CDER, clinical trials, DDMAC, FDA, first-line treatment, Gleevac, Novartis, off label promotion, oncology, unbranded websites, warning letters
2 Comments
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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