When Pricing Pressure Reaches the FDA File: Practical FDA Realities

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In this second part of our series in collaboration with White & Case and BRG , Wayne chat s with Bethany Hills, P artner at White & Case , and Dan Troy, Managing Director at BRG . Together, they discuss where pricing pressures show up at FDA; how pricing issues affect how companies should think about evidence packages, differentiation claims, and life-cycle expansion; product features that often become flashpoints in pricing issues with FDA; lawful product differentiation versus differentiation that may later be portrayed as regulatory gaming; why CMC issues, manufacturing resilience, and shortage risk become more consequential amid pricing pressure; documentation surrounding regulatory and…