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Tag Archives: postmarketing
FDA Guidances – December 2010
Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in December 2010, including a few from the first week of January 2011 … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged adverse events, FDA, guidance, in vitro diagnostics, labeling, postmarketing
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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
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FDA Begins Releasing Safety Analyses of Recently Approved Products
The safety of the people shall be the highest law. – Marcus Tullius Cicero Evaluating drug safety is, as I’m sure you know, always an exercise in measuring risks and benefits. One question that can haunt the dreams of companies … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged clinical trials, FDA, FDAAA, postmarketing
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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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