Tag

regulatory
Cord Blood Derived HCT

Cord Blood-derived HCT/Ps Remain ‘351 Category Products – Part One

Back in mid-February, I was at the IOF Conference and was a part of a panel discussing various aspects of the questionable regulatory compliance by companies selling products that contain cord blood-derived components, including viable cells, among other issues. I was shocked to learn of the extent that the free-for-all in regenerative medicine involved donor cord...
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Changing Therapeutic Environment

Lessons for the FDA From Their Workshop on Draft Guidances – Part Two

After reviewing comments made by a considerable number of speakers at the September FDA Workshop on the four draft Guidances (Part One, Part Two, Part Three, Part Four), I switched over in the last post to what I thought were some of the critical issues and lessons the FDA might have learned from the testimony...
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Lessons for the FDA

Lessons for the FDA from their Workshop on Draft Guidances – Part One

Over the past four posts on the FDA Workshop on Draft Guidances (Part One, Part Two, Part Three, Part Four) I have reviewed comments from speakers at the Workshop on draft Guidances the FDA held this past September. With all due respect to the speakers and their heartfelt presentations, I see the FDA changing only...
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SVF Preparation

FDA Workshop on Draft Guidances – Part Four

Over the past three posts (Part One, Part Two, Part Three) I have highlighted several themes that have struck me as I review the presentations made at the FDA’s Workshop on the pending four draft Guidances. I have tried to handicap the likelihood that positions taken and relief requested by the speakers would sway the...
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Fat Tissue Issue

FDA Workshop on Draft Guidances – Part Three

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...
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Safe Medical Environment

FDA Workshop on Draft Guidances – Part Two

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. The theme I had started with was the irony associated with certain speakers of large corporations wishing to cut...
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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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Odd Comments About Regulatory Affairs

Catching Up on Regulatory Affairs – Part Two

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...
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Regulatory Affairs

Catching Up on Regulatory Affairs – Part One

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) Minimal Manipulation (December, 2014; source) Adipose...
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