not accept submissions via e-mail or CDs. Companies may submitted two-sided copies of DMFs. DMF reviews (Category 3) When the FDA receives a DMF, they review it for administrative content. This may take 2–3 weeks. If the DMF is acceptable from an administrative point of view, the FDA issues an acknowledgement letter, which notifies the holder of the DMF number. If the FDA finds the DMF not acceptable from an administrative view, they notify the holder of the deficiencies they must correct. The FDA reviews the DMF for technical information only after the following events occur: The DMF holder submits a Letter of Authorization (LOA) in two copies to the FDA. This LOA must contain the DMF number. The holder sends a copy of the LOA to the authorized party (customer). The customer submits an application to the FDA that contains a copy of the LOA. Pre-assignment of DMF Numbers (Category 3) The FDA grants requests for preassigned DMF numbers for electronic or paper DMFs. (See Requesting a Pre-Assigned Application number.) Format and content of the application's Chemistry, Manufacturing, and Controls section (Category 1) Companies submit DMFs following the format recommended in the Guidance for Industry M4Q: The CTD - Quality. Conversion to Common Technical Document Companies may convert an existing DMF in non-CTD format to CTD format. In such cases, the FDA advises DMF holders to submit an amendment that contains all applicable CTD-specified sections to the material in the DMF. Each section must be complete and current. For drug substances and excipients, companies must submit all sections of 3.2.S in Module 3. For drug products, companies must submit all sections of 3.2.P in Module 3. If the reformatting causes changes in the DMFs technical content—e.g., adds new information—the cover letter for the new submission must describe these changes. DMFs in CTD format must follow CTD Guidance, e.g., be paginated within each section. This supersedes DMF guidance. For conversion of a paper DMF to electronic CTD format, see Electronic DMF. DMFs that cover multiple items, e.g., Type III DMFs for components of container-closure systems or Type IV DMFs for flavors, can be submitted in CTD format. Technical information can be in Module 3, following the outline in the Drug Substance Section. Sections within 3.2.S. can be populated as appropriate. Each product, such as different flavors, must have a different name—e.g. 3.2.S.[Flavor 1], 3.2.S.[Flavor 2]. Information common to different products—e.g.,