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Tag Archives: accelerated approval
Accelerated Approval
Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics: … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged accelerated approval, clinical benefit, DDMAC, efficacy, FDA, postmarketing, safety, surrogate endpoint
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
