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# Guide on Controlled Correspondence Related to Quality
- URL: https://www.fdaweb.com/guide-on-controlled-correspondence-related-to-quality/
- Published: 2021-09-20T12:00:00.000Z
- Updated: 2026-09-14T17:15:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150177

FDA has released a [draft guidance](http://FDA has released a draft guidance %28XXINSERT LINKXX%29entitled Questions and Answers on Quality-Related Controlled Correspondence. The document provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in generic drug controlled correspondence submissions to CDER’s Office of Pharmaceutical Quality %28OPQ%29 regarding chemistry, manufacturing, and controls, and %28XXX SUBSTITUTE XXX%29product quality microbiology. The guidance is intended to proactively respond to %28XXX DELETE XXX%29scientific and regulatory topics that appear frequently in controlled correspondence addressed by OPQ, “thereby allowing industry to move forward with certain generic drug development activities without the need to submit controlled correspondence to FDA,” the agency says.) entitled *Questions and Answers on Quality-Related Controlled Correspondence*. The document provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in generic drug controlled correspondence submissions to CDER’s Office of Pharmaceutical Quality (OPQ) regarding chemistry, manufacturing, and controls, and product quality microbiology. The guidance is intended to proactively respond to scientific and regulatory topics that appear frequently in controlled correspondence addressed by OPQ, “thereby allowing industry to move forward with certain generic drug development activities without the need to submit controlled correspondence to FDA,” the agency says.