Placement of DMF Reference Letters
Mar14

Placement of DMF Reference Letters

Rather than submit key information in Module 3 of an application (ANDA, BLA, IND, or NDA), it’s become increasingly common for sponsors to reference a Drug Master File (DMF). Referencing a DMF allows the component manufacturer of the drug or biologic to share proprietary information with the US FDA without having to directly share the information with the sponsor.

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Rules for Submitting Electronic DMFs to FDA, Health Canada
Jan14

Rules for Submitting Electronic DMFs to FDA, Health Canada

The U.S. FDA and Health Canada have each updated their submission requirements for Drug Master Files (DMFs). Understanding each agency’s requirements will be critical to compliance in the coming months as eCTD mandates go into effect.

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FDA Provides Clarification for Organizations Submitting ANDAs

The Generic Drug User Fee Amendments (GDUFA) introduced user fees to the organizations participating in the bioequivalent drug industry and incentivized filing Abbreviated New Drug Applications (ANDAs) electronically. The law functions as an informal mandate by promising expedited review times to applicants who submit to the US FDA in eCTD format. Another GDUFA stipulation addressed the Refuse-to-Receive (RTR) designation for ANDA...

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