FDA injunction

August 9, 2010

THE US FDA is currently seeking an injunction against Regenerative Sciences for violations of current good manufacturing practice which have caused the adulteration of its cultured cell products. Having not been approved by the FDA in the first instance, the cell product is derived from a patients own bone marrow or joint fluid, to be grown processed and mixed with drug products outside the body before being re-injected to the patients body. The FDA has also said that the product is misbranded as it lacks adequate directions for use and fails to bear the “Rx only” symbol. The injunction would see the product prevent the company from adulterating and misbranding their cultured cell products. For info see www.fda.gov.

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Pharmacy Daily | FDA injunction

FDA injunction

Other recent headlines

MDR’s results surpass expectations

Call to restructure CSO

Camden takes top spot

SEARCH PHARMACY DAILY

Featured video

Recent issues

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