Entries Tagged 'FDA' ↓

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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FDA Regulation of Regenerative Medicine Products

Welcome to the Regenerative Medicine Guru Blog

The focus of this blog will be to provide information on how regenerative medicine products are regulated in the U.S.

It is intended to be a knowledge portal for those interested in the development of regenerative medicine.

We will go in depth into the process to successfully develop a regenerative medicine product in the U.S. including common pitfalls to avoid.


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