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.