About Regenerative Medicine Guru

Welcome to Regenerative Medicine Guru – the knowledge portal to help regenerative medicine products reach the clinic sooner.

Greetings, this blog is maintained Darin Weber and I occasionally post my thoughts on the Regenerative Medicine Guru blog. By the way, I recognize I’m not a ‘guru’ when it comes to all things regenerative medicine, no one is. It is a catchy title for a blog, though don’t you think? However, I do hope that in some small way the information you will find on this blog will help you in your own quest to become a guru in whatever branch of science and/or technology that touches upon regenerative medicine.

My primary goals are to provide some practical information about interacting with regulatory authorities, particularly the U.S. Food and Drug Administration (FDA). Consequently, from time to time I intend to post information I hope will help you become more informed about:

  • How scientific research in regenerative medicine is translated into a medical product to benefit patients
  • What activities and data are needed to satisfy the requirements of regulatory authorities, such as the U.S. Food and Drug Administration (FDA), so my regenerative medicine product can be administered to patients
  • How regenerative medicine products are regulated in the United States
  • Some of the common stumbling blocks in the development of regenerative medicine products that can delay or even doom successful commercialization
  • The pros and cons of engaging a consultant to work on your regenerative medicine product.

Most of the information you see on this blog comes from my experience as both a product development consultant and from my experiences at the FDA. I hope that by making this information freely available, it will benefit your efforts to successfully develop regenerative medicine products for patients with unmet medical needs.

About Darin

See my profile on linkedin: http://www.linkedin.com/in/weberd