RE: new day19 Jun 2019 14:31
Drug developers are free to ask for help from FDA at any point in the drug development process, including:
Pre-IND application, to review FDA guidance documents and get answers to questions that may help enhance their research
After Phase 2, to obtain guidance on the design of large Phase 3 studies
Any time during the process, to obtain an assessment of the IND application
Even though FDA offers extensive technical assistance, drug developers are not required to take FDA’s suggestions. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.