Guidance Outlines New Review Procedure for Some Type II DMFs

February 19, 2016

CDER is tightening up its protocols for companies submitting data about active pharmaceutical ingredients used in generic drugs.

The agency said it will begin conducting completeness assessments for all Type II drug master files — which detail the manufacturing, production and storage processes for APIs — slated to appear in an ANDA.

The final guidance expands on a draft guidance issued in October 2012 and outlines the elements required for a successful Type II DMF API submission. CDER will consider:

  • Whether the DMF still is active;
  • If the DMF previously has been reviewed;
  • Whether the submitter has paid an administrative DMF fee;
  • If it pertains to a single API; 
  • Whether the submission includes a completed checklist;
  • If the DMF contains all of the information needed to enable a scientific review; and
  • Whether the submission is written in English.