Through the FDA Safety andInnovation Act and the Pre-scription Drug User Fee Act,the FDA is expanding its efforts toexpedite the development andreview of promising therapies forserious conditions using fast-track,breakthrough-therapy, acceleratedapproval, and priority-review desig-nations. In these cases, the FDAmay engage in more presubmissioncommunications with sponsors andreview applications in 6 months,enabling the drug to be made avail-able once it is determined that ben-efits outweigh risks. Orphan-drugand fee-waiver designations providefinancial incentives to drug compa-nies, but do not affect the reviewprocess.
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