The Senate on Wednesday voted 64-36 to approve a budget that will protect FDA user fees from sequestration cuts for the next two years. Read More

HHS stands by its final rule expanding the discounts for orphan drugs that hospitals and healthcare providers can apply when used to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More

To satisfy new Australian guidance on supplier qualification for raw materials, drugmakers need to stop using one-size-fits-all questionnaires and adopt screening methods that are specific to the products they are making. Read More

The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing last week that outlines how it intends to approach one contentious issue involving compounders. Read More

While breakthrough therapy designation for new drug products has taken off dramatically at CDER, the FDA’s CBER has not moved quickly to approve applications for the new designation. Read More

The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More

U.S. lawmakers Wednesday introduced a bill that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More

The FDA’s John Taylor, acting deputy commissioner for global regulatory operations and policy, will leave the agency in January for unnamed opportunities, FDA Commissioner Margaret Hamburg told staff in a memo Wednesday. Read More

Prosecutors appear ready to lean more heavily on the False Claims Act in prosecuting off-label marketing cases, sidestepping a ruling in the U.S. Second Circuit that found off-label promotion was protected free speech and not prosecutable under the 1938 FD&C Act. Read More