Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product

The Generic Drug User Fee Amendments (GDUFA) include provisions for DMF fees, a completeness assessment, and communications with DMF holders for Type II DMFs for drug substances (active pharmaceutical ingredients (APIs)) used to support ANDAs. These provisions do not apply to other types of DMFs or to Type II DMFs used to exclusively support NDAs or INDs. For more information about GDUFA as it relates to Type II DMFs, see:

For submissions of sterility assurance information, see:

Additional Resources

Type III Packaging Material

FDA does not require that packaging information be submitted in a DMF. NDA, ANDA, or BLA applicants or IND sponsors who receive information from the manufacturer of a packaging component or material of construction may include that information directly in the application. If, however, the manufacturer does not wish to share information with the applicant or sponsor (i.e., because it is considered proprietary), it may be placed in a Type III DMF and incorporated into the application by a manufacturer’s letter authorizing reference to the DMF.

For submission requirements related to Type III DMFs, see guidance for industry Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Rev.6). Revision 7 of this guidance has been issued as a draft for public comment and includes a proposed exemption for Type III DMFs. When final, this guidance will represent FDA’s current thinking on this topic.

For submissions of sterility assurance information, see:

Additional Resource