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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
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
The FDA is not backing down on its stance that Novartis abused the citizen petition process to stall approval of generic versions of Reclast, and the agency has rejected a company request that it retract its statements from the public record. Read More
A new House bill aims to build on the success of the Generating Antibiotics Incentives Now (GAIN) Act by allowing drugmakers to submit less data for antibiotics and antifungals that affect limited patient populations. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More