Additional resources are described below that may be informative in your exploration of drug development tools.
Critical Path Innovation Meetings
Critical Path Innovation Meetings (CPIMs): A meeting with CDER to discuss a proposed methodology or technology and obtain general advice from CDER on how this methodology or technology might enhance drug development. Other FDA centers participate in CPIM meetings when cross-cutting issues arise that involve a broader audience.
Through this program, FDA expects to become more familiar with prospective innovations in drug development, broadening its regulatory perspective. The discussions and background information submitted through the CPIM are drug1 product-independent and are nonbinding for both the FDA and CPIM requestors.
Over the past several years, FDA has engaged with external stakeholders to develop resources that can be utilized to bring efficiency into the overall drug development and regulatory processes. Examples of such resources are:
- CDER Data Standards Program: A comprehensive program within CDER to identify and prioritize data standards needs and to implement good practices for standards development. FDA also has a webpage on study data standards for submissions to CDER and CBER that may be of interest.
- BEST (Biomarkers, EndpointS, and other Tools) Resources: A glossary of biomarkers and endpoints in basic biomedical research, medical product development, and clinical care.
Return to Drug Development Tools (DDTs)
1The term drug refers to both human drugs and biological products unless otherwise specified.