OGD/U. MARYLAND BIOEQUIVALENCE SOFTWARE CONTRACT IS AGENCY "TOOL KIT,"
Executive Summary
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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth