FDA To Review MDS Pharma's Bioequivalence Data From Last Five Years
This article was originally published in The Pink Sheet Daily
Executive Summary
A recent FDA inspection of MDS Pharma Services' Montreal bioanalytical facility has triggered an agency review of all bioequivalence studies conducted at the facility over the last five years. The contract research organization is reviewing its quality assurance practices.
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MDS Pharma Services (Correction)
FDA has recommended that MDS Pharma Services conduct an expanded review of bioequivalence studies conducted at the company's Montreal bioanalytical facility over the last five years
MDS Pharma Services (Correction)
FDA has recommended that MDS Pharma Services conduct an expanded review of bioequivalence studies conducted at the company's Montreal bioanalytical facility over the last five years
FDA To Scrutinize MDS Pharma Bioequivalence Study Methods
CRO’s approach to investigating sources of contamination in bioequivalence studies is “inadequate,” the agency says in an “untitled” letter. MDS says it is “actively working to address the agency’s concerns.”