FDA Action Needed On Competition And Shortages
JAMA Study Of FDA Data Calls For More ANDA Approvals
A study published by the Journal of the American Medical Association found that, despite a recent stream of FDA activity, the proportion of approvals for drugs that faced limited competition or had previously been in shortage remained steady.
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The AAM has commended the FDA’s efforts on identifying the root causes of drug shortages in 2019 and has committed to work with the agency in pursuit of a “healthy, sustainable market for safe, effective and affordable medicines for patients.”
As the FDA breaks its record for generic drug approvals in fiscal year 2019, it emphasizes the importance of consumer confidence in the safety and quality of approved generics.
The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.