After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.

Draft guidance describes seven types of confirmatory evidence that can be used with one adequate and well-controlled clinical study to demonstrate substantial evidence of effectiveness, including evidence from expanded access, real-world data, and studies of other drugs in the same class.

DOJ and Chamber of Commerce attorneys argue over whether Chamber has standing to sue and whether AbbVie has suffered harm meriting a preliminary injunction to halt the program. With Medicare’s Oct. 2 deadline looming, Judge Newman said he would issue a decision ‘as quickly as we can.’

Pink Sheet infographic details the district court judges and circuit courts that will be deciding the cases brought by industry against the IRA, breaking down the Democrat and Republican appointees as well as the arguments in each suit.

Ahead of Friday’s hearing on US Chamber of Commerce's suit against HHS, attorneys discuss potential remedies and carveouts to Inflation Reduction Act's drug price negotiation provisions, harms to industry that may support a preliminary injunction, and what would prompt Supreme Court review.