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Office of Research Regulatory Affairs
IND Support Services Form
Main Phone: 5015266876
Fax: 5015266272Protocol Title/IRB #
Principal Investigator
Contact Person
IND/FDA Submissions Carole Damon 5267437;
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Who needs regulatory affairs ind support?
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What is regulatory affairs ind support?
Regulatory affairs IND support refers to the assistance provided in navigating the regulatory processes associated with Investigational New Drug (IND) applications, ensuring compliance with the guidelines set by regulatory authorities.
Who is required to file regulatory affairs ind support?
Sponsors of clinical trials, typically pharmaceutical companies or research institutions, are required to file regulatory affairs IND support to initiate clinical investigations of new drugs.
How to fill out regulatory affairs ind support?
To fill out regulatory affairs IND support, one must gather relevant clinical and manufacturing data, provide a detailed study protocol, and comply with the required format and guidelines provided by regulatory authorities.
What is the purpose of regulatory affairs ind support?
The purpose of regulatory affairs IND support is to ensure that new drugs are developed and tested according to regulatory standards, facilitating their approval for clinical use while safeguarding patient safety.
What information must be reported on regulatory affairs ind support?
Information that must be reported includes study protocols, drug manufacturing information, preclinical study data, and safety and efficacy data related to the drug being investigated.
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