Forms and templates are referenced in the SOPs where applicable.
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Optimally, the pre-IND meeting establishes a working relationship between the sponsor and the FDA that facilitates ongoing dialogue leading up to the IND submission and throughout the product development life cycle.
After the submission of the original IND and initiation of clinical studies, communication with the FDA is primarily maintained through the submission of IND amendments, such as new clinical protocols, safety reports, or updated manufacturing information.
Sponsors can increase the likelihood of receiving a positive review decision from the Agency by ensuring that the original IND is detailed and complete, and addresses any potential safety concerns associated with the investigational product.
Many resources are available to assist sponsors in the preparation of a successful IND.
Abstract Vaccines provide the most effective means of preventing potentially serious infectious diseases and play a critical role in public health management.