FDA has approved a record 1,028 generic drugs for FY2019, already shattering the record 971 approvals in FY2018. As Acting FDA Commissioner Ned Sharpless points out, the number of approvals isn’t the only measure of success; FDA continues to “work with industry to improve the quality of their applications.”
Want to dig deeper into generic drug policies and programs?
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Article
FDA Q&A: Generic Versions of Narrow Therapeutic Index Drugs
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Overview of the (FDA) Generic Drug Program and Surveillance
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Optimal Anti-Cancer Drug Profiles for Effective Penetration of the Anti-Cancer Drug Market by Generic Drugs in Japan
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Podcast
US Generic Drug Policy: Less Cost, Same Impact
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Video
Generic Drug Products: Comparison of Safety Profile with Branded Cousin
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Howard Chazin, FDA