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Bioequivalence protocol reviews will take longer for drugs with more than three years' patent life left -- OGD.

Executive Summary

BIOEQUIVALENCE PROTOCOL REVIEWS FOR DRUGS WITH THREE YEARS OF PATENT LIFE or more left before expiry will take longer than those for products with less than three years of patent protection left, Office of Generic Drugs Acting Director Douglas Sporn informed generic drug firms in an Aug. 18 letter.

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