Entries Tagged 'combination product' ↓

New FDA Proposed Rule will Impact Regenerative Medicine Products

For those involved in creating regenerative medicine products that combine cells with various biomaterials, such as natural or synthetic scaffolds, you should be aware that the FDA recently issued a new Proposed Rule for these types of medical products.  In regulatory speak these are “combination products” since each component can be regulated separately.  For example, cells are regulated as biological products and most scaffolds are regulated as medical devices. So a regenerative medicine product consisting of cells and scaffolds is defined by the FDA as a biologic-device combination product.

The new Proposed Rule describes in somewhat confusing detail when the drug-biologic good manufacturing practice (GMPs) will apply to these products versus the medical device quality systems regulations (QSRs).  In a nutshell, the manufacturer of a combination product can decide to either adopt QSR regulations or adopt GMP regulations for the manufacturing or choose a hybrid approach.  Here are the 3 main choices i gleaned from my quick read of the rule:

  1. If you already have a quality system based on the medical device QSR regulations you can continue to use this system.  However, you may need to augment your quality system to include some GMP specific requirements.
  2. If your firm already has a quality program based on the GMPs, you can continue using the GMPs, but may need to augment some elements of the medical device QSRs that are missing.
  3. The alternative either of those approaches is to apply medical device QSRs to only the medical device component and GMPs for the biologic component.  For example, if your regenerative medicine product consists of ex vivo expanded cells that are seeded onto a synthetic scaffold, one could envision a hybrid quality program that ensures the cells (biological product) are manufacturing according to GMPs and the scaffold would be manufactured according to medical device QSRs.

One issue that is not entirely clear, particularly for a regenerative medicine product, is how the designation of a “Lead” FDA Center will influence the choice in the quality approach that is most appropriate.  The “Lead” FDA Center is the group that will review and ultimately approve the medical product.  While there are a lot of similarities between QSRs and GMPs, I’m not sure I would want to choose the QSRs if my combination product is going to be reviewed by CBER, which is more familiar with the GMPs.  Similarly, choosing the GMPs for a combination product that is reviewed by medical device reviewers in CDRH, would probably not be a wise decision.

Like any new proposed rule, I am sure there will be a number of comments from stakeholders in industry and academia. If you want to make a comment on this proposed rule, here is the link to do so online.  Comments are due by 22-December 2009.

–Darin

What the Heck is a Regenerative Medicine Therapy?

My favorite working definition for regenerative medicine is any medical intervention that is intended to repair, replace, restore or regenerate (the 4 R’s) the cellular, tissue or organ systems in the human4Rs.jpg body. As described by one of my former FDA colleagues, Dr. Steven Bauer, cellular therapies represent one branch of regenerative medicine that on their own can fulfill the 4 R’s. However, it is clear that many other medical technologies will contribute to the field of regenerative medicine. See my post on how the FDA views the world of regenerative medicine.

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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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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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