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 [...]
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