CDER Outlines Process for Engaging in NoE Program

CDER released a Manual of Policies and Procedures outlining the process for engaging scientific, medical or clinical organizations for its Network of Experts program.

The program allows CDER staff to access a network of scientific experts within two weeks of defining a scientific question.

Under the process, the CDER coordinator emails current NoE organizations when specific scientific questions emerge, according to the MAPP released last week.  The network organizations then issue email requests for experts, and ask prospective experts for resumes or CVs.

Once the experts are screened, a “highly structured” conference call takes place with CDER to discuss the questions.

The MAPP can be accessed at www.fdanews.com/10-29-15-mapp.pdf.