On Monday morning at the Arizona Biltmore in Phoenix, Karim Mikhail opened the Alliance for Regenerative Medicine’s 2026 Cell & Gene Meeting on the Mesa. Mikhail became the permanent Director of FDA’s Center for Biologics Evaluation and Research in September. CBER leadership has turned over a lot this year, so the room was listening closely […]
In our global industry, the FDA does not want to fall behind countries like China and Australia where first in human studies have an expedited pathway. Operation Trialblazer is designed in part to do that for US companies. It is described by HHS and FDA as an “initiative to modernize and accelerate clinical drug development […]
CDER published a study titled “First-Cycle Complete Response Rates for CDER NDA and BLA Applications” (here). I read and reread it a few times and I am still confused. It appears that FDA published this report to counter industry’s stated belief that the number of Complete Response Letters (CR) have increased over time. This is […]
Today, on the Federal Register’s pre-publication page, the FDA published the new fee that must be submitted for use of a priority review voucher. The notice (here) establishes the “FY 2027 priority review fee rate for use of tropical disease, rare pediatric disease, and material threat MCM priority review vouchers at $1,798,596” (the FY 2026 […]
Keep an eye on your mailbox and get ready to open your checkbook! FDA says: “The annual FY 2027 PDUFA program fee invoices were emailed on Tuesday, August 18, 2026. Please note that the invoices are only sent to firms with PDUFA user fee eligible products. If you do not receive your FY 2027 program […]
The announcement in the prepublication of the Federal Register of the new FY 2027 PDUFA user fees for NDAs and BLAs might be a bit of a pleasant surprise to sponsors as the decrease in fees is something we usually do not see. Perhaps it is due to the significant staff reductions seen during the […]
With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows: Administrative/Procedural – 8 Artificial […]
The pharmaceutical supply chain is no longer just a chain of physical materials, but rather a complex series of data, data-based decisions, and delegated responsibilities for that data. FDA’s CDER FY2024 Site Catalog reported 4,619 manufacturing sites globally, reflecting the broad scale of the regulated manufacturing network supporting the U.S. drug supply. Within that network, […]
The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]
The new draft guidance “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products” (here) provides the industry with a foundation for providing one adequate and well-controlled study with appropriate confirmatory supporting data to satisfy the Agency’s requirement for demonstrating safety and efficacy. While this may, on its face, appear to be a boon […]
