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FDA’s March activities report on the generic drugs program show that after a drop off in ANDA approvals in January and Feb- ruary from Jan./Feb. 2017, the number rebounded in March. The decline in the first two months has been attributed in part to companies needing to implement the impurity expectations outlined in FDA’s draft guidance and ICH Q3D. ANDA submissions
(129) and withdrawals (146) increased significantly in March, while the number of complete response letters fell dramatically.
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