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Tag Archives: CDER
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
Comments Off
FDA Realigns Divisions and Current Applications
Effective 15 March 2010, the FDA will be realigning several key review divisions within the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND). Importantly, this means that the review responsibility for many applications (eg, INDs, NDAs, … Continue reading
