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.
US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.