NEW YORK, March 31 (GenomeWeb News) - MDS will voluntarily and temporarily wind down all its commercial bioanalytical liquid chromatography and mass spectrometry operations in Montreal in order to accelerate a review by the US Food and Drug Administration, the company announced today.
MDS received a letter from the FDA shortly after the end of the second quarter of 2004 that brought up issues with a bioequivalence study conducted in the company's
A recent audit by the FDA identified a number of issues pertaining to the effectiveness and management of MDS' five-year review.
"I am disappointed that we have not made progress at the rate necessary on this review," said Stephen DeFalco, president and CEO of MDS. "We are en
Commercial activities will continue in MDS' other bioanalytical sites in