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- W753610067 abstract "Clinical research conducted at academic medical centers significantly contributes to discovery and development of drugs and devices and to the repurposing of FDA-approved products. Many such studies require FDA oversight through the Investigational New Drug (IND) or Investigational Device Exemption (IDE) designation. Investigator-initiated research requires the investigator to serve as a sponsor-investigator and the “holder” of an IND/IDE. This role involves complex submissions to and interactions with the FDA, but investigators may be poorly prepared or resourced to meet these additional obligations. An increasing number of academic medical centers offer regulatory support for sponsor-investigators. Presently, we describe one high-volume regulatory support program at a large medical center. Several critical challenges occur in the initial steps of investigator collaboration – gap analysis, protocol refinement, and industry interaction. Select case studies reveal both specific challenges and successful approaches. FDA regulatory compliance is challenging for under-resourced sponsor-investigators. Given the complexity of FDA regulatory requirements, early support for sponsor-investigators can accelerate study execution and completion and is a growth asset to the academic research enterprise." @default.
- W753610067 created "2016-06-24" @default.
- W753610067 creator A5084759395 @default.
- W753610067 creator A5087718744 @default.
- W753610067 date "2012-04-01" @default.
- W753610067 modified "2023-09-26" @default.
- W753610067 title "Trials and tribulations ‐ FDA regulatory support for academic sponsor‐investigators" @default.
- W753610067 doi "https://doi.org/10.1096/fasebj.26.1_supplement.851.1" @default.
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