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OTP Pre-IND Meetings | FDA

fda.gov · 2,824 words · saved by 1 readers

The .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Pre-IND Meetings can be valuable for sponsors in procuring feedback on a sponsor’s product development program, especially if a sponsor’s questions are not fully answered by guidance documents and other publicly available resources. A Pre-IND Meeting can also provide information that will assist sponsors in preparing to submit complete investigational new drug (IND) applications and reduce the risk of a clinical hold. The primary purpose of this meeting is to review and obtain feedback on the design of preclinical studies, the design of the initial IND study, and product manufacturing and quality controls needed to initiate human studies. The meeting also pr

Pre-IND Meetings can be valuable for sponsors in procuring feedback on a sponsor’s product development program, especially if a sponsor’s questions are not fully answered by guidance documents and other publicly available resources. A Pre-IND Meeting can also provide information that will assist sponsors in preparing to submit complete investigational new drug (IND) applications and reduce the risk of a clinical hold. The primary purpose of this meeting is to review and obtain feedback on the design of preclinical studies, the design of the initial IND study, and product manufacturing and qual

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