An organization with a robust quality system will have established policies and procedures, so it should be no surprise that CDER has a full set. By law, these must be available to the public, so they have been published on the CDER website as the CDER Manual of...
Medicine
What is a Drug Master File (DMF)?
A Drug Master File, or DMF, is a submission to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. There are four types of DMFs: Type...
New Modules posted on CDRH Learn
CDRH posted seven new modules on the CDRH Learn web page at the end of September/beginning of October. These new modules are: Under The Basics How is CDRH Structured? Is My Product a Medical Device? Under How to Study and Market Your Device Introduction to the...