Thursday, December 16, 2010

Sponser Meeting with FDA some facts

There are many meetings which a sponser can have with FDA related to the product being developed and to be approved by FDA. But it can be categorized in to 3 base categories.

Type A: Critical Path (Urgent) meetings – Clinical hold, Safety Issues, Site disqualification, etc (within 30 days)
Type B: Procedural meetings – Pre-IND meeting, EOP2, pre-NDA, etc (within 60 days)
Type C: Miscellaneous meetings – CMC issues, mid-P3, early-review, mid-review, etc ( within 75 days)
Formal meetings are not the only way you communicate with the FDA: comment requests, emails, telecons with the RPMs, etc.

Why meeting FDA?

- Sponsors have the right to request a meeting with the FDA review division
- These meetings are specifically to help prescription drug approvals
–Not granted if FDA perceives that an IND is not being planned
–More for issue resolution while product development than scientific rationale
–Clarification and discussion, not “interrogation”
- Pre-submission meetings (pre-IND, EOP2, pre-NDA) meetings are considered critical by FDA compared to mid-cycle meetings (mid-P3, mid-review, etc)

Time for meeting
1. Developed “final product” idea
–Finished formulation
–Target indication(s) and population(s)
2. CMC information
–Manufacturing and packaging (cGMP)
–Stability studies
3. Basic non-clinical studies (GLP)
–Acute and sub-acute toxicology
–In vitro toxicity tests
4. Ready to initiate clinical studies
5. Have sufficient GMP level investigational product
6. The pre-clinical studies demonstrate MTD, NOAEL, major expected adverse events
7. Scientific rationale for mechanism of action is available
8. Clinical development plan is proposed

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