What FDA resources are available for information about communicable diseases and problems with HCT/Ps?
There are two Web sites that provide information on new procedures: For Procedures for Handling Adverse Reaction Reports Related to “361” Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), go to http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm073048.htm. For tissue-related information, go to http://www.fda.gov/cber/tissue/docs.htm. 7. How are incidents reported? While pilot sites are participating in the FDA Tissue and Cell Pilot Project with MedSun, they should report on problems with cells and tissues in the same way they report on device problems—using the secure MedSun online software or by phone or fax—and then supplement the report with details about the HCT/P, as requested on the list provided to the sites. Sites that are not involved in the pilot project should send reports to the product distributor using the MedWatch FDA Form 3500A. 8. What are the benefits of this project? There are benefits to the part
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