Tag Archive: in vitro diagnostics

Oct 06 2010

September 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 September 2010 (links go directly to PDF documents). Special Interest Guidances/Information Date Posted Safety Reporting Requirements for INDs and BA/BE Studies (Draft) 09/28/2010 Suicidality: …

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Jul 09 2010

June 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 June 2010 (links go directly to PDF documents). Special Interest Guidances/Information Date Posted CMC Postapproval Manufacturing Changes Reportable in Annual Reports (Draft) 6/24/2010 Frequently …

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Jun 18 2010

DIA 2010 – Week in Review

The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location.  In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas of the Agency. As previously mentioned, Will Lee and I attended the meeting.  For those …

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