US DMF - Interesting Facts

US DMF Interesting Facts

There is no legal or regulatory requirement to file a DMF.

DMFs are neither approved nor disapproved.

FDA customarily reviews the technical contents of DMFs only when an IND sponsor, an applicant for an NDA, ANDA, BLA or Export Application, or another DMF holder incorporates material in the DMF by reference.

FDA will not review a DMF until the DMF holder submits a letter of authorization (LOA) to the DMF regarding a specific application.

There are no “Open” and “Closed” part of a DMF in the US, as there are in Europe. All parts are considered “closed.”

Four Types of DMFs are available in US

DMF Types Subject of Information Provided in the DMF Type II Drug substance, drug substance intermediate, and materials used in their preparation, or drug product. Type III Packaging material Type IV Excipient, colorant, flavor, essence, or material used in their preparation Type V FDA-accepted reference information

Type I DMFs were discontinued in 2000 but the numbering of the other DMF types has not changed.

Changes in DMF to be updated to agency through amendment.

Failure to submit an annual report could result in the termination of DMF.