FDAnews Announces — New Management Report — Navigating HCT/P Regulations: Risks and Opportunities for Drug and Device Manufacturers

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The regenerative medicine industry is rapidly growing and, with major court decisions, new and significant FDA guidance, and government enforcement actions, the regulatory landscape is more complex than ever. With the Navigating HCT/P Regulations management report, 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.

Navigating HCT/P Regulations:
Risks and Opportunities for Drug and Device Manufacturers
**An FDAnews Management Report**
http://www.fdanews.com/hctpregsmr    

The regenerative medicine industry is rapidly growing and, with major court decisions, new and significant FDA guidance, and government enforcement actions, the regulatory landscape is more complex than ever.

With this management report, 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.

Who Will Benefit:

  • Regulatory Affairs
  • Quality Control
  • Legal
  • Business Affairs

Management Report Details:
Navigating HCT/P Regulations:
Risks and Opportunities for Drug and Device Manufacturers
Price: $397
http://www.fdanews.com/hctpregsmr    

Easy Ways to Order:
Online: http://www.fdanews.com/hctpregsmr            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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