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Tag Archives: postmarketing
Divisive Devices or UFC 510(k): FDA Meets IOM
In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices. This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, clinical trials, FDA, manufacturing, medical devices, PMA, postmarketing, safety
1 Comment
Social Media in Clinical Trials: Increasing Patient Recruitment
When you become sick with a virus or are seeking information about a diet, where’s the first place that you turn to for help? Is it the doctor’s office or the internet? A recent study showed that the percentage of … Continue reading
Posted in Clinical Trials, Social Media
Tagged advertisements, clinical trials, enrollment, FDA, guidance, HHS, patient recruitment, postmarketing, Social Media
2 Comments
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
1 Comment
