Innovation Pays: Priority Drugs Drove Novel 2011 Approvals To New Heights
The new molecular entity and novel biologic class of 2011 isn’t just the largest since 2004 – CDER also posted near-perfect on-time review performance while maintaining healthy rates of first-cycle approvals and a low 15 month average time to approval, thanks to a high level of innovation in the novel product candidates.
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The agency suggests that categorizing approved drugs by level of novelty and tracking approvals by category is a better metric than NME count and should be the basis for assessment of the programs created by FDASIA to speed development of innovative products.
Generic Pharmaceutical Association, with research from IMS Health, says the savings to the U.S. health care system from using generic drugs were $1.07 trillion over the past 10 years, a figure the group believes should be taken into consideration when looking for solutions to the general fiscal crisis facing the U.S. The association is going to focus on improving generic utilization on state and local level.
FDA met most user fee performance goals for NDAs and BLAs received in fiscal years 2000 through 2010, the government watchdog agency says in a report prepared for Sens. Burr and Coburn. The legislators proposed legislation April 16 that includes a requirement for the agency to report annually on its adherence to the user fee goals.