Skip to main content
Premium Trial:

Request an Annual Quote

MDS to Wind Down Mass Spec and LC Operations in Montreal to Hasten FDA Investigation

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 Montrealfacility in 2001. In response to the letter, MDS embarked upon a retrospective review of bioanalytical studies conducted in the facility from 2000 through 2004.

 

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 enhancing the leadership and project management of this effort in order to complete this review to the FDA's satisfaction. Finalizing this effort in a high quality way is the top priority for the company."

 

Commercial activities will continue in MDS' other bioanalytical sites in Lincoln, Neb.;; Blainville, Quebec; Zurich; and Sittingbourne, UK, the company said.

The Scan

Another Resignation

According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug.

Novavax Finds Its Vaccine Effective

Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19.

Can't Be Used

The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports.

PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More

In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.