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Tag Archives: in vitro diagnostics
New FDA Guidances Released in July 2011
Here’s a list of the guidances released by FDA in July 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device In Vitro Companion Diagnostic … Continue reading
New Guidances from FDA – June 2011
Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biologics, cancer, Cato Research, FDA, guidance, IDE, in vitro diagnostics, manufacturing, medical devices, OTC, PMA
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New Guidances from FDA – May 2011
Here’s a list of the guidances released by FDA in May 2011 (along with a couple that were released inthe first week of June), compiled by Cato Research Regulatory Scientist Cathy Anderson. Commercially Distributed In Vitro Diagnostic Products Labeled for … Continue reading
Posted in FDA
Tagged ANDA, clinical investigator, FDA, financial disclosure, guidance, in vitro diagnostics, labeling, medical devices, submissions
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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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FDA Guidances – November 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 November 2010 (links go directly to PDF documents).
Posted in FDA, Regulatory Strategy
Tagged Cato Research, cell therapy, clinical trials, eCTD, FDA, guidance, in vitro diagnostics, medical devices
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