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Expert Analysis

2 Traps For Unwary ANDA Filers

Law360, New York (January 2, 2014, 6:04 PM EST) -- Companies looking to file an abbreviated new drug application ("ANDA") in 2014 should be aware of two draft guidances issued by the U.S. Food and Drug Administration this month. The draft guidances address bioequivalence standards for ANDA products and physical attributes of generic tablets and capsules, respectively....

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