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MMD PETITION, RESPONSE TO BIOAVAIL SUIT QUESTIONS FDA AUTHORITY

Executive Summary

MMD PETITION, RESPONSE TO BIOAVAIL SUIT QUESTIONS FDA AUTHORITY to "permit 505(b)(2) applications at all for non- bioequivalent versions of ANDA eligible drugs," Peter Safir of Kleinfeld, Kaplan and Becker told the Food & Drug Law Institute annual conference in Washington, D.C. Dec. 13. Safir is counsel for Marion Merrell Dow in its legal wrangles with Hoechst and Bioavail over sustained-release diltiazem.
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PS025486

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