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Generic Drug Assessment Times Show Improvement In GDUFA Performance Report

 
• By Derrick Gingery

Averages likely will increase as more of the cohort is approved, however.

FDA Approved typed words on a vintage typewriter
Average generic drug application approval times decreased throughout the first five-year GDUFA program cycle. • Source: Shutterstock

Generic drug application approval times dropped substantially during the first user fee program cycle, suggesting the US Food and Drug Administration and sponsors are making progress streamlining the process.

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More from Biosimilars & Generics

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