FDA Product-Specific Guidances Page Updated; Nearly 50 New Guidances Added

On August 15, 2017, FDA updated its page entitled Product-Specific Guidances for Generic Drug Development. In October 2016 we reported that “FDA Adds 67 New/Revised Product Specific Bioequivalence Guidances.” This latest addition is noteworthy because it includes finalized bioequivalence guidances, which the Agency has not done since September 2015. Click here to see the additions or here for help with your complex generic development program.

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