GDUFA Facility Fees Should Be Waived Until First ANDA Approved, Petition Argues
Bangladesh-based Square Pharmaceuticals says the fees are burdensome for first-time filers, given long approval times, but the firm’s citizen petition strategy may further delay approval of its ANDA.
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The agency also says only Congress could enact fee waivers and exemptions, but Square Pharmaceuticals indicates it will join lobbying efforts to create them.
FDA’s drastically expanded arrears list for FY 2014 fees totals more than 100 generic drug facilities; more than 40 still owe the FY 2013 fee.
Another outside candidate is expected to eventually take over for the departing director Gregory Geba, and while the Office of Generic Drugs can run smoothly without a permanent leader for now, it cannot do so forever.