New guidance on elemental impurities may have contributed to the dramatic slide in ANDA approvals in January.
The US FDA's Office of Generic Drugs reported only 25 full approvals in January, which is nearly 68% less than...
ANDA Approvals May Be Hindered By New Elemental Impurities Requirements
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US FDA's generic approval total in January was dramatically lower than recent monthly tallies, raising questions about impact of requirements that took effect at beginning of the year.
Learn what's happening at the US FDA. On the go.
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