GDUFA Facility List Lags Last Year, May Be Trailed By Higher Fees
Fewer generic drug facilities have self-identified with the agency than the same time in 2013, perhaps due to their capital situation.
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Small business owners say the GDUFA facility and other fees are too expensive, especially while waiting for ANDAs to be approved, but any small business waiver is unlikely until GDUFA II.
Industry officials say sponsors have to police all the facilities they use and reference to make sure ANDAs are not held up or exclusivity lost.
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.