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FDA Refuse-To-File Decisions Are Rare, But CMC And Ignoring Agency Advice Are Often Triggers

 
• By Sarah Karlin-Smith

Offering a unique peak behind the curtain at data that US FDA is generally prohibited from disclosing and that companies typically choose to keep secret, an agency analysis of two decades worth of refuse-to-file letters found the decisions can add a year and a half to a drug’s approval timeline.

refusing to file - 182843126 - shutterstock
FDA analyzes 10 years of refuse-to-file letters in a new journal article • Source: Shutterstock

US Food and Drug Administration refuse-to-file letters are generally issued for “substantive” deficiencies such as missing information needed to evaluate a product’s quality, safety, and efficacy, a new agency-led analysis of 103 refuse-to-file letters issued between 2008 and 2017 found.

The letters, which are issued when the agency determines a drug application is not complete enough for a full assessment, identify “foundational issues in drug review,” the study authors, led...

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More from Pathways & Standards

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
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A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
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