Manufacturing Daily Summary
Manufacturing Daily Summary: What Happened on October 23, 2026
CMC requirements remain a late-stage risk in rare-disease drug development
A separate podcast discussion covered Merck’s manufacturing capacity, supply network and use of digital tools.
Today in brief
Elisabeth Gardiner and Donny Xu called chemistry, manufacturing and controls (CMC) the biggest late-stage risk for rare-disease drug developers.1 Xu said unmet CMC requirements led several companies to receive FDA complete response letters, not deficiencies in safety or efficacy data.1
CMC requirements can derail rare-disease applications
Gardiner and Xu identified CMC as the biggest late-stage risk for developers of rare-disease treatments.1 Xu said several companies had received FDA complete response letters because they had not met CMC requirements, rather than because of inadequate safety or efficacy data.1
Also worth knowing
-
P
On the Pharmaceutical Executive Podcast, Merck’s Dave Maraldo discussed U.S. capacity investments, manufacturing partners, digital tools and efforts to strengthen agility and resilience in the supply network.2