ANDA Approval Records Will End As US FDA Mops Up Backlog
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
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US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.
December's ANDA rush has provided the largest monthly haul in two years. However, the month may be losing its influence over the US FDA's annual submission total.
However, the month may be losing its influence over the US FDA's annual submission total.