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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
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
Looking to add to its growing skin care product portfolio, Valeant Pharmaceuticals said Monday it will acquire medical devicemaker Solta Medical for $250 million. 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
Drugmakers should review the marketing contracts they have in place with pharmacies or other third parties to ensure the information they send to patients complies with new HHS limitations. 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
The House late Thursday passed a comprehensive budget deal that, in easing some of the pain of sequestration, puts the FDA’s fiscal 2014 outlook in the hands of congressional appropriators typically friendly to the agency. Read More