Draft Guidances

FDA Workshop on Draft Guidances – Part One

The FDA held a two-day stakeholder meeting on September 12 and 13 to review four draft Guidances the Agency wants to finalize. In this post, and several upcoming posts, I will review the comments of individuals who wanted to have their voices heard at the Workshop. The speakers were to comment on the following four...
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FDA Comes A Knockin'

When the FDA Comes A Knockin’

Previously in posts Hello From Greyledge and Is There a Way to Refine the Practice of Regenerative Medicine?, I introduced Greyledge Technologies and the service it provides to physicians and surgeons who have decided to use platelet rich plasma (PRP) and bone marrow concentrated cells (BMCC) either as adjunctive therapy during a surgical procedure or...
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Hello From Greyledge

I would like to take this opportunity to introduce myself to readers of the Blog on the Greyledge Technologies website. Some of you might be familiar with posts I wrote for a blog maintained by Celling Biosciences (Austin, TX). The change in websites reflects a change in my employment, as I now am Vice President...
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