Lots of topics have been discussed on the first two days of the Association for Accessible Medicines (AAM) Fall Technical Conference.  Many of the detailed presentation and speakers’ comments had what I refer to as hidden gems that might have escaped full view.  Here are some of the noteworthy tidbits:

  • What about those ANDAs that have had complete responses? When will they come back to the Agency?  FDA wants to know! This is important for resource planning.  With about 1750 ANDAs pending with industry, wouldn’t it be nice for the Office of Generic Drugs to know that maybe 500 or so will never be subject to amendment?  You bet!
  • Pre-ANDA submission meeting requests should be clear, concise, and direct to the point. No need to use fancy language or overexplain what you want to do.  Keep questions direct and don’t use multiple sub-questions.  This will help FDA be able to respond to your questions more direct and responsive.
  • Meeting request or controlled correspondence? That question is important to get the appropriate request into the Agency in the correct format.  There is specific guidance for product development meeting. Make sure you know what is appropriate for a pre-meeting request and be prepared for the 120 days for the meeting to be scheduled as that was what was negotiated for the GDUFA II program.  While FDA might do something earlier, don’t ask for a shorter goals date.  As an old professor of mine used to say, “Don’t try to teach a pig to sing, it wastes your time and annoys the pig.”
  • Justification of the major/minor classification in OGD’s Complete Response Letters (CRLs). This is something the industry has been asking for and now there will be a separate section in the FDA’s CRL providing how and why the decision was made.

That’s it for now, but stay tuned from more happenings from the meeting.