There are three main themes that I have discussed so far that have stood out during my review of the two-day Workshop the FDA held on September 12 and 13. These themes are: Corporate needs should dictate the interpretation and application of the law that governs the use of patient-derived materials (including dead peoples’ parts [...]
Part One of my review of the speakers’ comments at the two-day stakeholder workshop the FDA held on September 12 and 13 to review four draft Guidances the Agency wants to finalize can be found here(opens in a new tab). The theme I had started with was the irony associated with certain speakers of large corporations [...]
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 [...]
In the last post, I had initiated a review of some really odd comments by an attorney, Mr. Richard Jaffe, on what he considers to be the free-for-all nature of a section of 21 CFR 1271—the law that controls the creation and use of human-derived materials, known as HCT/Ps, which was published in 2001 in [...]
While I was settling in at my new job with Greyledge Technologies in Colorado, the FDA held a two-day stakeholder meeting to review four draft guidances the Agency wants to finalize. The four draft guidances are (in the order they were issued): Same Surgical Procedure Exception (October, 2014; source(opens in a new tab)) Minimal Manipulation (December, 2014; source(opens in [...]
In the first post of the Greyledge Blog, I introduced the Blog, Greyledge Technologies and my recent shift in employment. I had left off with describing aspects of the service Greyledge provides to physicians who wish to have tighter control over the composition of autologous PRP and BMC preparations for use in a physician’s practice [...]
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