OGD/U. MARYLAND BIOEQUIVALENCE SOFTWARE CONTRACT IS AGENCY "TOOL KIT,"
OGD/U. MARYLAND BIOEQUIVALENCE SOFTWARE CONTRACT IS AGENCY "TOOL KIT," FDA Associate Director for Scientific & Medical Affairs Roger Williams, MD, told a joint Pharmaceutical Research & Manufacturers of America/FDA meeting on computerized NDA filings Nov. 1 in Washington, D.C. Williams praised the Access/OGD bioequivalence software that the collaboration has developed, stating: "We have a data set come in, you query it with these tools, and you produce the review. It paves the way for transparency of data." FDA hopes the software will accelerate review time for ANDAs and supplements.
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