Can I obtain a more formal evaluation of my study design or investigational plan through a determination and/or agreement meeting?
Yes. (See the Glossary for definition of terms.) A guidance document regarding these meetings, “Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff,” is available on the Internet. CBER also follows this meeting guidance document when determination and/or agreement meetings are requested.
Related Questions
- Once I sign the Partner Plan Agreement and complete the design phase, can I change my mind and decide not to hire BrentMore to complete my project?
- Can I obtain a more formal evaluation of my study design or investigational plan through a determination and/or agreement meeting?
- What is required to obtain an Agreement in Lieu of an Erosion & Sediment Control Plan?
