The FDA's Best Tips For Avoiding Drug Master File Setbacks
Impurity assessment and starting materials justification are the top reasons for deficiencies related to Type II drug master files in first-cycle DMF reviews while the US FDA continues to see "hidden facilities" that are listed in DMFs but not the ANDAs they are linked with.
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FDA says 16% of ANDAs have an issue with "hidden facilities" that are listed in drug master files but not the ANDAs they are linked with; industry official offers some tips to bridge this communications gap with DMF holders.
The US FDA has made a renewed effort to clarify the types of manufacturing facilities that need to be listed on the Form FDA 356h and Module 3 of the CTD in submissions. Often reviewers find this information missing, whicn can result in a refuse to file action.
Although compounding of certain shortage drugs is allowed during the public health emergency, remdesivir is off limits due to its complexity. Providers should only use the FDA-approved version of the drug, Gilead’s Veklury, the agency says.