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Tag Archives: PDF
New FDA Guidances – December 2011/January 2012
Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be … Continue reading
Posted in FDA
Tagged 510(k), biomarkers, CDRH, eCTD, FDA, guidance, IDE, in vitro diagnostics, IND, manufacturing, medical devices, off label promotion, PDF, safety, vaccines
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FDA Issues New PDF Specifications
In the chaos of the holidays, you might have missed the release of an important new guidance from FDA. On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at the … Continue reading
