Tissue pooling
This article was originally published in The Gray Sheet
Executive Summary
FDA's Center for Biologics Evaluation and Research will not take regulatory action against Regeneration Technologies while it is reviewing additional data on the Alachua, Florida firm's BioCleanse tissue sterilization system, according to a May 16 CBER letter. The center issued an untitled letter to RTI May 3 informing the firm that the BioCleanse did not conform to FDA's proposed rule on current good tissue practice, which prohibits pooling tissue from multiple donors during manufacturing (1"The Gray Sheet" May 14, 2001, p. 8)
You may also be interested in...
RTI Pooling Methods Conflict With Tissue Practices Rule - CBER
Regeneration Technologies, Inc.' s BioCleanse system for pooling tissue from multiple donors is not validated to conform to FDA's Jan. 8 proposed rule on good tissue practices, FDA states in a May 3 letter to the firm.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.