Dermagraft to resubmit US PMA (pre-market approval) within two months:
This article was originally published in Clinica
Advanced Tissue Sciences has completed the enrolment of subjects for its trial of the human tissue-based Dermagraft skin graft in treating diabetic foot ulcers. The La Jolla, California-based company expects to submit a PMA to the US FDA before the end of September. The company's first PMA, in 1998, was rejected by the agency.
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.