US FDA Catches Up On Monograph Petitions: Denies Antiseptic TFM Requests Made In 2001
Agency’s recent responses denying three petitions filed in 2001 by US industry trade groups and in 2002 by pharmaceutical ingredient and chemicals firm explain the changes requested can be proposed in “OTC monograph order requests” pathway established in program overhaul.
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Draft acknowledges firms likely will expect refunds when they withdraw OMORs. When sponsor withdraws OMOR before FDA accepts or refuses to file, agency will refund 75% of the without a written request. But refunds aren’t so simple if an OMOR is withdrawn later in process.
Submitting other OTC monograph program communications through CDER's NextGen Portal, including proposals to add formulations or indications to a monograph, will have to wait.
Latest plan, agency’s second annual following debut in 2021, lists monograph activities FDA intends to address over next three years. “FDA’s decision‐making regarding which activities to place on the forecast is generally guided by public health priorities,” it says.