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Tag Archives: FDA
CDRH Proposes Changes to the 510(k) Pathway
All for one, one for all, that is our device. – Alexandre Dumas The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, FDA, guidance, medical devices
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Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective
Image via Wikipedia This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. The Joint Statistical Meetings is often a good place to learn about emerging issues in the … Continue reading
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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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
July 2010 FDA Guidances
Image via Wikipedia 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 July 2010 (links go directly to PDF documents). Special … Continue reading
Posted in FDA
Tagged cardiovascular, FDA, guidance, ICH, IND, medical devices, nonclinical research, transdermal
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