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For those of you who are still new to here (less than 10 years on boards), I would like to refer one of the newest articles that I encountered which basically does a very good job summarizing a lot of the research, experimentation and findings which...

# Temp. Regulatory Affairs Specialist 1 - 151951 Hologic, Inc\. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in...

Written by Todd Brian, Validated Software. In Part 1 of this series, we looked at off-the-shelf software, and the costs of saftey-critical products. In Part 2, we examined the processes for developing and validating safety-critical products. In this...

Within the past few years, the single-use technology (SUT) arena of the biopharmaceutical industry has exploded in growth. Leading organizations have predictably and understandably stampeded to the “watering hole” of single-use to drink up the advantages...

*Proposed Order: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products* *CDRH is temporarily posting this proposed order on our website. Later this afternoon, it will be on advanced display for public inspection...