FDA Allows Certain DMF Exemptions in eCTD Guidance
Certain DMFs provided to support an application on packaging or packaging may be exempted from the electronic Common Technical Document (eCTD) format, the agency said.
Non-eCTD submissions of Type III DMFs will be easier to handle, the agency believes. The DMFs are often submitted not by drugmakers but by material suppliers and packagers, the agency noted.
In addition, some Type II DMF submissions may receive a waiver for noncommercial applications, such as ones from an academic institution, government or non-profit research group.