How To Use DMF Content To Support Your Application To The FDA
How To Use DMF Content To Support Your Application To The FDA By S. D. Devendra Raj, Ph.D., Freyr A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA at the discretion of the DMF holder to assist its customers. A DMF is used to provide confidential detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing one or more active pharmaceutical ingredients (APIs) and/or human drugs in the absence of rel...
United States Sd Devendra Raj Office Of Pharmaceutical Quality Devendra Raj Electronic Submissions Gateway Pharmaceutical Quality
Source: pharmaceuticalonline.com