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Latest From Brenda Sandburg
Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.
Walgreen and other retailers allege no-authorized generic patent settlement for extended-release metformin allowed Santarus (Valeant) to block generic entry for four years while raising the price more than 750%.
Regeneron advocates industry-FDA collaboration to establish regulatory standards for novel applications of genomic data, such as determining whether long-term outcomes studies are needed, and inclusion of the data in product labeling.
Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.