FDA revamps CMC review
This article was originally published in The Tan Sheet
Executive Summary
The Office of New Drug Quality Assessment has been established to replace FDA's Office of New Drug Chemistry and will become effective Nov. 1, the agency announces Oct. 5. ONDQA will operate within the Office of Pharmaceutical Science to help implement a "risk-based pharmaceutical quality assessment system" to replace the current chemical, manufacturing and controls (CMC) review process. ONDQA is "designed to be more efficient, effective, and flexible in managing CMC issues and workload," the agency adds. The new office will review the CMC section of Investigational New Drug applications, New Drug Applications and NDA supplement applications. ONDQA will be headed by Moheb Nasr, PhD, who currently serves as ONDC director...
You may also be interested in...
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.