TORONTO--(BUSINESS WIRE)--Feb. 7, 2005--As part of its ongoing
dialogue with the U.S. Food and Drug Administration (FDA), MDS Pharma
Services met with the Agency on February 2nd, 2005 to present and
discuss a plan to review bioequivalence studies conducted at the
company's Montreal Bioanalytical facility.
During the meeting, the FDA indicated that they concurred with
the overall approach of the review plan, with minor modifications,
which will be incorporated by MDS Pharma Services.
The review plan presented to the FDA provides a standardized
mechanism for conducting a comprehensive review of bioequivalence
studies conducted at the Montreal facility between 2000 and 2004. The
studies will be reviewed in order of priority based on specific
criteria described in the plan, following appropriate review
processes and quality assurance checks. The need for detailed
subsequent review, analysis and corrective action, if any, will be
determined as results of the individual study reviews are obtained.
The company has devoted dedicated resources to this review and
will begin the process immediately. The FDA will receive periodic
updates on the progress of the review. MDS Inc. is committed to
complete cooperation with the FDA in the execution of this plan.
MDS Inc. senior management and Board members have been active in
an oversight role in the development of the review plan. In addition,
MDS Inc. had retained Lachman Consultant Services Inc., a highly
knowledgeable and respected advisor, to provide independent advice to
the MDS Inc. Board and to assist in the review plan development.
Lachman will also be involved in overseeing the execution of the
review plan by MDS Pharma Services.
Due to the comprehensive nature of the review, it is not possible
at this time to accurately project when the review will ultimately be
completed. However, MDS Pharma Services is confident that its
allocation of dedicated resources will enable the diligent and
effective execution of the review plan, without impairing its ability
to continue to conduct ongoing and future customer studies at the
site. MDS Inc. is committed to continuing an open dialogue with
customers and other interested stakeholders on the progress of this
review.
MDS Pharma Services offers a full spectrum of resources to meet
the drug discovery and development needs of the pharmaceutical and
biotechnology industries. With 37 facilities in 21 countries, the
company applies advanced scientific and technological expertise to
each stage of the drug discovery and development process: discovery,
preclinical, early clinical research (bioequivalence, phases I-IIa),
bioanalysis, global clinical research (phases IIb-IV), and central
lab. For more information, visit MDS Pharma Services' Web site at
www.mdsps.com.
MDS Pharma Services is an integral part of MDS Inc.
(TSX:MDS)(NYSE:MDZ). MDS Inc. has more than 9,000 highly skilled
people in 25 countries providing a diverse range of superior products
and services to increase our customers' speed, precision and
productivity in the drug development and disease diagnosis processes.
We are a global health and life sciences company, recognized for our
reliability and collaborative relationships. Please refer to our
website at www.mdsintl.com to find out more about how we help create
better outcomes in the treatment of disease.
MDS PHARMA SERVICES (TSX:MDS) (NYSE:MDZ)