FDA demands another trial for artificial skin
This article was originally published in Clinica
The FDA has told the maker of Dermagraft that it must start a new trial of the artificial skin in the US before it can be approved for diabetic foot ulcer patients. This is despite a conditional recommendation for approval from an advisory panel early this year. The move could set back sales of the skin for this application by as much as two years.
You may also be interested in...
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA neuroscientist Andrew Shen.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.