On Monday, September 20, 2021, a guidance document entitled Questions and Answers on Quality Related Controlled Correspondence (here) hit the FDA webpage late in the afternoon.  This document provides specific recommendations for generic drug quality issues that have been the raised repeatedly through controlled correspondence (CCs) submitted by numerous stakeholders.  OGD decided to issue the responses to these questions to help reduce the need for CCs asking the same or similar questions.

This was actually a suggestion that I made at what is now the GRx – Biosims Conference a couple of years ago during my presentation on Controlled Correspondence.  I don’t know if that triggered this document or if OGD/OPQ did this on their own initiative.  Nonetheless, I applaud the Agency for being proactive in categorizing recurring straightforward questions and providing concise answers that firms can take to the bank when making their ANDA submissions.

The questions cover the following areas:

  • Bracketing/Matrixing
  • Container-Closure Changes
  • Dissolution
  • Microbiology (Endotoxin testing)
  • Number of Batches
  • Stability Orientation Requirements
  • Packaging
  • Scoring and Split Tablet Testing
  • Size and Shape of Generic Solid Oral Dosage Forms


In addition, the guidance refers you to appropriate guidance documents upon which support for the answers is derived.  A good read and could eliminate a 60-day wait for a response to a CC that you may be writing now.