Entries Tagged 'GTPs' ↓

Human Tissues: Never Trust, Always Verify

On October 13, 2009, the FDA posted on its website a news release from the U.S. Attorney concerning a California man who on multiple occasions falsified records related to the suitability of human tissues for clinical use.  This is unfortunately just one example of problems with those supplying human tissues.  Follow this link to the FDA’s website to see recalls involving human tissues. I find this personally disturbing on a number of levels, particularly given the important role donated human tissues play in addressing a number of medical conditions and the generally low level of donation of tissues and organs.  Reports such as these, certainly can’t help those striving to improve the rates of tissue and organ donation.

Since many regenerative medicine products utilize cells and tissues as ‘starting materials’ to create new medical products, this news release should remind all of us to never assume the cells or tissues you are using are suitable, unless you have reviewed the documents and verified they meet the donor eligibility requirements under the FDA’s good tissue practice (GTP) regulations.  Of course verifying the quality of materials should be done for all components used in the manufacturing process, but additional emphasis must be given to human or animal origin materials.

It would be ‘nice’ if you could trust your suppliers from the very beginning, but unfortunately, there are unscrupulous individuals who are either ignorant of the requirements, or just don’t care.  Fortunately, there are an increasing number of ‘quality aware’ suppliers for the regenerative medicine field. Our task to always think about the patients who may receive our products and to ensure that the materials used to create them are of the highest quality possible.


My 2008 Presentations & Articles Relevant to Regenerative Medicine

2008 was an extremely busy year for me, as I am sure it was for you as well. The net result is that I have been slow to post updates and thoughts regarding translation of regenerative medicine products to the clinic. In the ‘better late than never” category, I thought I would share some of the presentations and relevant articles I have written over the past year.

Links are provided for most of the presentations and articles I have generated over the past year.

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How Does the FDA View the World of Regenerative Medicine?

A major focus of the Regenerative Medicine Guru Blog is the development of new medical interventions based on regenerative medicine.

Therefore, it is important to understand how the ‘gatekeepers’ view this field. In the U.S., the Food and Drug Administration (FDA) is the key gatekeeper. You may be surprised to learn that there is not a specific regulatory pathway spelled out for regenerative medicine products.

Instead, the FDA’s approach is to examine each specific regenerative medicine product and determine the regulatory pathway based on the most important component(s) of the regenerative medicine product. To accomplish this, the FDA essentially conducts a thought experiment in which the regenerative medicine product is ‘de-constructed’ in order to identify the key components and ask the question, which component(s) are most important in providing benefit to the patient.

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