CDER Releases Revised MAPP on Scientific Interest Groups

The FDA’s Center for Drug Evaluation and Research (CDER) has issued a newly updated manual aimed at the agency’s staff, but useful for the regulated community as it allows a window into how the FDA is planning to handle certain internal activities.

The new manual of policy and procedures (MAPP) outlines the requirements for creating a scientific interest group (SIG) in the Office of Clinical Pharmacology (OCP) within CDER.

A SIG, different from a working group, is a collection of volunteer members with a common interest in a particular scientific topic. OCP encourages the formation of SIGs to support professional development based on personal scientific interests, develop increased scientific expertise within OCP and provide opportunities for mentorship within OCP.

The revised SIGs manual adds clarity on the steering committee’s role for these groups and OCP staff involvement in SIGs.