Generic Drug Patent Challenge Notifications Will Be Announced By FDA
Executive Summary
FDA will soon begin posting announcements of ANDAs that have been filed with Paragraph IV certification on the Office of Generic Drugs web site.
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FDA should specify that ANDAs which change certification from Paragraph III to Paragraph IV should trigger for a 30-month stay, the Pharmaceutical Research & Manufacturers of America states in comments on FDA's proposed rule
PhRMA Wants Amended ANDAs To Trigger 30-Month Stays
FDA should specify that ANDAs which change certification from Paragraph III to Paragraph IV should trigger for a 30-month stay, the Pharmaceutical Research & Manufacturers of America states in comments on FDA's proposed rule
FDA Generic Drugs Office’s Scientific Advisory Team Will Direct Research
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