Sen. Cassidy Suggests Importing Generics From EU To Pressure US Prices
Idea may require tweaking existing agreements between FDA and EMA, but is another twist on drug importation, a concept that FDA opposes.
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Brand 'Evergreening' Piques FDA Interest, But Solutions Remain Elusive
Agency eager to hear suggestions on the subject, also known as product hopping, but even reform advocates were cautious of stifling meaningful reformulations of products.
Drug Pricing: Could Expedited Review Of Competing Brands Create The Desired Pressure?
Payer groups suggest during FDA's Hatch-Waxman meeting that agency prioritize NDAs moving into the same class to push prices lower.
FDA Exploring Whether Public Shaming Can Stop REMS Abuses
Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.