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As more critics of the FDA’s approval of the painkiller Zohydro ER come forward, the agency says it will not limit approval of new opioid painkillers to those with abuse-deterrent properties. 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
The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More
While FDA’s CDER breakthrough therapy designations for new drug products have taken off dramatically, CBER has been a lot more conservative in approving applications for the new designation. Read More
A citizen watchdog group is again raising concerns about conflicts of interest on FDA advisory committees, charging that the agency should not have allowed a panel member to vote on a drug that a family member was taking. Read More
U.S. lawmakers Dec. 11 introduced legislation 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 does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing earlier this month that outlines how it intends to approach one contentious issue involving compounders. Read More
GlaxoSmithKline unveiled a new compensation system for its global sales force this week in a move hailed as a revolutionary change to improve ethical practices for drug sales professionals. But so far it’s a revolution of one. Read More
HHS stands by its final rule expanding 340B discounts to orphan drugs when certain hospitals and healthcare providers use them to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More
Former InterMune CEO W. Scott Harkonen’s crusade to challenge his felony conviction in a closely watched free speech case collapsed after the Supreme Court declined to hear his appeal. Read More
French authorities on Thursday fined Merck $21.5 million for its efforts to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More