Tim Wright, Editor, Contract Pharma02.06.23
It can take more than a decade and hundreds of millions of dollars to develop a new therapeutic. It is a dynamic process that requires precise timing and a clear strategy to stay on track. One of the first major milestones within drug development is submitting an investigational new drug (IND) application to the U.S. FDA’s Center for Drug Evaluation and Research (CDER).1 The main goal of an IND is to provide regulators with data that supports the drug’s safety and suitability for use in humans.
When an IND fails to adequately demonstrate safety, all drug development activities stop. In those cases, the U.S. FDA orders a clinical hold—i.e., a delay or full suspension—of all or part of a proposed clinical investigation until sponsors can respond with justification for their processes and/or address data deficiencies. The U.S. FDA cites these as the most common reasons for clinical holds:2
• Product quality: A product has an impurity profile indicative of a potential health hazard or cannot remain chemically stable throughout testing.
• Pharmacology and toxicology: Data from non-human st
When an IND fails to adequately demonstrate safety, all drug development activities stop. In those cases, the U.S. FDA orders a clinical hold—i.e., a delay or full suspension—of all or part of a proposed clinical investigation until sponsors can respond with justification for their processes and/or address data deficiencies. The U.S. FDA cites these as the most common reasons for clinical holds:2
• Product quality: A product has an impurity profile indicative of a potential health hazard or cannot remain chemically stable throughout testing.
• Pharmacology and toxicology: Data from non-human st
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