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The Generic Drug User Fee Amendments (GDUFA) are central to FDA oversight of generic drug manufacturers, but navigating the requirements isn’t always straightforward. Self-identification, program fees, and DMF submissions create recurring challenges that can be costly if misunderstood or overlooked.     In this session, Melissa Sayers, Drug Regulatory Manager, will simplify the complexities of GDUFA…

Did you know that two of the most common reasons food products are refused entry into the U.S. are labeling mistakes and illegal food additives? Many companies don’t discover that their products are not permitted in the U.S. market until it is too late, and they are detained at port. Recent FDA actions add to the…