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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