FDA issued a new draft guidance entitled”Draft Guidance for Industry; How To Prepare a Pre-Request for Designation”. This guidance is intended to describe informal interaction with FDA that might lead to a formal Designation request to determine wether a product will be regulator as a device or a drug and some combination thereof. The full...Read More
“Being Agile & Compliant”
2-day Public Training Course
Tampa, Florida USA
Feb 18-19, 2019
Come meet John F. Murray, Jr., who recently retired from FDA and joined SoftwareCPR®, at the course!
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