Navigating HCT/P Regulations: Risks and Opportunities for Drug and Device Manufacturers

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Navigating HCT/P Regulations
Risks and Opportunities for Drug and Device Manufacturers

With the Navigating HCT/P Regulations management report you will learn what uses of human cells and tissue are regulated and when the FDA requires an HCT/P to go through the marketing approval process including:

  • The three criteria the FDA uses to determine whether an HCT/P falls under its jurisdiction.
  • The four draft guidances in which the agency establishes its regulatory policy.
  • Two court cases that have helped shape regulation of regenerative medicine.
  • The distinction between two classes of HCT/Ps and which one is quickest to market.
  • The steps involved in applying for a license to market.

Navigating HCT/P Regulations explains where and how the FDA has set the medical product line and what practitioners of regenerative therapies must do to comply with the agency’s regulations.


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