Why need a Pre-IND Meeting before new drugs are confirmed?

The Pre-IND Meeting is the new way of getting the opportunity to communicate and discuss your questions with the FDA about your current programs. An FDA pre IND meeting is basically a quality assurance process that is used to confirm clinical data management or integrity and regulatory compliance. The most common FDA inspection is the regular inspection prompted by a New Drug Application submission. Accomplishing this will conduct preclinical and clinical processes and develop a target development profile before the development process, which improves the chance of a successful development program and decreases the chance of encountering expensive uncertainties. By this context of particular concern is clarity in the Investigational of New Drug innovation. 

Clients looking for the pre-IND meeting must request a meeting with the FDA, which can be an opportunity to build a relationship with the FDA and gain valuable feedback on any questions regarding drug development. Although the FDA accomplishes not need these conferences, they are recommended because such arrangements can confirm the needs of the development process. It may be helpful to meet with the FDA earlier in the drug development process to incorporate any suggestions and answers to questions into the outcome program. 

These meetings are most effective when they focus on specific scientific or regulatory issues, such as clinical trial design, pharmacology studies, toxicology studies, acceptability of novel formulations with safety, and efficacy to support new drug approval. In order to ask for a pre-IND meeting, people must submit a standard letter to the reliable project administration staff or other assigned personnel of the Division of Transplant and Ophthalmology development Products.

The timing of the pre-IND meeting usually depends on the sophistication of the conversation topics. Supporters who choose to receive verification of toxicology methods and manufacturing will help from a conference that had 6 months to 1 year previous to the planned IND submission planned. In such circumstances, a meeting submission should be presented approximately 60 days before the preferred appointment date.

In addition to Pre-IND Meeting, the FDA offers other opportunities to engage for guidance on development programs formally.1 Type-A meeting are held to help move along a stalled development program. Type C meetings are any other meetings between the FDA and a sponsor regarding the development of a product.

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