May 4, 2026 · 46 min · 16 segments
Wayne chats with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates. You'll hear their…
No entities detected.
From the pharma desk, uh, FDA reported progress after the first year of its roadmap to reduce animal testing.
Animal testing has been a big issue for s- for, for some time in drug development.
Uh, FDA is now relying more on, uh, computer models, laboratory-based human systems.
Uh, the effort, of course, is to phase out, to the extent possible, certain animal, uh, studies.
The agency also released a follow-up report outlining progress to date and next steps for continuing the transition toward non-animal testing, uh, approaches.
From the devices desk, CDRH issued a letter to provide manufacturers of CDRH lead combination products with information pertaining to potential nitrosamine, uh, impurities.
The letter described manufacturer responsibilities and highlights resources that may assist in identifying and managing potential nitrosamine impurities in device products.
This, uh, letter is available on the FDA website, fda.gov. From the foods desk, FDA recently issued warning letters to three food companies after inspections found serious violations in their facilities.
I mention them not because I wanna focus on these particular facilities, but because there have been concerns about the activity of the human foods program.
I recently heard Kyle Diamantes, the Deputy Commissioner for Foods, talk to the Alliance for a Stronger FDA about plans for the 2027 budget.
We've had a number of episodes on that, and, uh, it, it's good to see that FDA continues to have an active human foods program.
Uh, I think, uh, Kyle Diamantes did a good job at the Alliance meeting in describing what, uh, FDA has been doing in that area and what they plan to do.
And then finally, from the cosmetics desk, FDA released a recording of a recent Grand Rounds presentation featuring experts from the Office of Cosmetics and Colors at FDA on cosmetic product regulations under MoCRA.
From the pharma desk, uh, FDA reported progress after the first year of its roadmap to reduce animal testing.
Animal testing has been a big issue for s- for, for some time in drug development.
Uh, FDA is now relying more on, uh, computer models, laboratory-based human systems.
Uh, the effort, of course, is to phase out, to the extent possible, certain animal, uh, studies.
The agency also released a follow-up report outlining progress to date and next steps for continuing the transition toward non-animal testing, uh, approaches.
From the devices desk, CDRH issued a letter to provide manufacturers of CDRH lead combination products with information pertaining to potential nitrosamine, uh, impurities.
The letter described manufacturer responsibilities and highlights resources that may assist in identifying and managing potential nitrosamine impurities in device products.
This, uh, letter is available on the FDA website, fda.gov. From the foods desk, FDA recently issued warning letters to three food companies after inspections found serious violations in their facilities.
I mention them not because I wanna focus on these particular facilities, but because there have been concerns about the activity of the human foods program.
I recently heard Kyle Diamantes, the Deputy Commissioner for Foods, talk to the Alliance for a Stronger FDA about plans for the 2027 budget.
We've had a number of episodes on that, and, uh, it, it's good to see that FDA continues to have an active human foods program.
Uh, I think, uh, Kyle Diamantes did a good job at the Alliance meeting in describing what, uh, FDA has been doing in that area and what they plan to do.
And then finally, from the cosmetics desk, FDA released a recording of a recent Grand Rounds presentation featuring experts from the Office of Cosmetics and Colors at FDA on cosmetic product regulations under MoCRA.
The rest of this transcript — segmented and speaker-labeled, so you land on the exact moment something was said
Search every transcript — by keyword, by phrase, or by meaning, across every show Radar indexes
Trends — what is surging across podcasts, measured against its own baseline
Alerts — when a name you follow appears in a newly indexed episode
No account is needed to search Radar.