FDA Says It’s The Law, Denies Petition Requesting GDUFA Fee Payment Changes
This article was originally published in The Pink Sheet Daily
The agency also says only Congress could enact fee waivers and exemptions, but Square Pharmaceuticals indicates it will join lobbying efforts to create them.
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Talks between industry and FDA focus on size of the discount and how a small business would be defined.
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.
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.