This is the second edition of the “Did You Know?” series featuring some of the lesser known (or at least widely known) aspects of the GDUFA III program changes and the impact on the generic drug industry.

Today we will focus on elements of Pre-ANDA Development Program.

GDUFA III has opened the door for additional meetings and methods to gain information about product development issues such as the controlled correspondence, product development meeting (PDEV), and the ANDA pre-submission meeting. The options available in this program are to:

  • Clarify regulatory expectations for prospective applicants early in product development;
  • Assist applicants to develop more complete submissions;
  • Promote a more efficient and effective ANDA review process; and
  • Reduce the number of review cycles required to obtain ANDA approval, particularly for complex products.

But do you know the main reasons these meetings are denied? According to FDA:

  • 36% denied because of incomplete meeting packages;
  • 32% should have been submitted as controlled correspondences and not for PDEVs;
  • 13% were outside of the scope of the commitment letter;
  • 10% had an inadequate meeting package;
  • 7% fall into an “Other” category; and
  • 1% were non-clarifying questions.

These figures demonstrate that firms should do their homework and prepare a package that demonstrates an understanding of the necessary elements of what should be contained in the package and also understand what is not covered under the meeting provisions.

OGD stresses the following are the types of issues that should be addressed in the PDEV meetings:

  • Studies on characterization of complex API, higher order structure, aggregation, etc.;
  • Impurity thresholds for products not covered under ICH guidance, or immunogenicity assessment;
  • Proposed physicochemical and structural characterization tests to demonstrate Q3 sameness;
  • Dissolution testing and other analytical methods;
  • Quality information for device or container closure system; and
  • Design of stability studies

FDA suggest you ask them specific questions about your development program and approach.  Know what is required for submission in the package. Provide adequate justification and preliminary data to support your proposed program but avoid data dumps. And most of all, refrain from asking review issues!

That’s it for this issue of “Did You Know?”. We will be back later in the week.