Post-market plans, formerly called regulatory agreements, will be piloted
This article was originally published in The Gold Sheet
Executive Summary
FDA is planning two pilots of post-market plans, the agency's new name for regulatory agreements, which would allow for extra flexibility, for example to make changes without filing supplements. The first pilot will be for companies that are submitting quality-by-design filings, Office of Pharmaceutical Science Director Helen Winkle told the PDA/FDA meeting in Washington on Sept. 24. The second pilot will be for filings that did not use the quality-by-design approach, either because they are for legacy products or for new products that don't need lots of QbD information or risk assessment work, but still could use some regulatory flexibility