Bowman Cox

I write on what’s new in biopharmaceutical manufacturing science, technology, quality and policy.

[Derrick @dgingery]

The latest @PharmaPinkSheet podcast is posted! Listen to @PinkSheetHobbs, @bowmancox and I discuss the @AccessibleMeds conference, FDA under Trump 2.0, and Hill hearings on drug shortages and foreign inspections #pinksheet #pharma: https://t.co/IRxcrThP4F

[Derrick @dgingery]

The commish @DrCaliff_FDA on the upcoming retirement of @DrWoodcockFDA from @US_FDA

[Sarah Karlin-Smith @SarahKarlin]

Janet Woodcock confirms to me she is indeed retiring. End of an era. HT to @davidalim and team.

[Bowman Cox @bowmancox]

@SarahKarlin Thanks for sharing here, Sarah. Looks like a direct hit on a product storage area at a major sterile injectables plant. So far it sounds like everyone there is OK. Wondering what folks have heard.

[LinkedIn Help @LinkedInHelp]

It’s not you, it's us! You may be having trouble viewing LinkedIn. Our teams are working to bring us back to your normally scheduled programming as soon as possible.

[Bowman Cox @bowmancox]

@SarahKarlin Thanks for the tweet, Sarah. This is just the tip of the iceberg. Stay tuned: https://t.co/0RGLOilu0P.

[Bowman Cox @bowmancox]

The report adds: "Early research
suggests that in contrast with treating chronic conditions as discrete pathologies, interventions to
delay aging would also increase resistance to multiple chronic conditions."

[Bowman Cox @bowmancox]

A pitch for #geroscience in today's National Academies report on healthy aging: "Prevention and care targeting aging pathways are predicted to have very different, and
better, outcomes compared with the current discrete disease–focused approach." https://t.co/zINGuB4XOc

[Bowman Cox @bowmancox]

When a story like this comes along, I can't help but wonder what @weeklyworldnews would have done with it. https://t.co/iAsqtnSXMu

[Bowman Cox @bowmancox]

#FDA has caught up on OAI follow-up #inspections, Shannon Brown reports.
https://t.co/lWlCBIFsud

[Jessica Huseman @JessicaHuseman]

if someone had told me in 2014, when I did not know what FOIA was, that @NiemanLab would be writing a story about a company I started to teach people how to file FOIs I would have asked, "How do you spell foy-ya" and then I would have laughed. https://t.co/kEIwrfTdfh

[Bowman Cox @bowmancox]

BARDA Lays Out Vision For Next Pandemic: Vaccines For The US Within 130 Days https://t.co/gDok9l0vXH

[Bowman Cox @bowmancox]

It's not an inspection, but #FDA just wants to look around? @ShawnMSchmitt reports that emergency use authorization Holders Shouldn’t Be Surprised If FDA Shows Up To Investigate https://t.co/EKJkfrLF5o

[Bowman Cox @bowmancox]

@dgingery's analysis of what to expect for Califf's second time around with Senate confirmation. https://t.co/NbDlyuL1R2

[Bowman Cox @bowmancox]

@dgingery finds Robert Califf Likely To Find Many Familiar Problems Upon His Return To US FDA https://t.co/EnYhFU32qr

[Bowman Cox @bowmancox]

@PinkSheetHobbs has been calculating Califf’s course to confirmation, and here's how it look: https://t.co/rK1ksWYs88

[Bowman Cox @bowmancox]

@ScripRegVibha shares the Real Story Behind COVID-19 Vaccine Safety Monitoring https://t.co/pHbqMN5uov

[Bowman Cox @bowmancox]

A dose of reality on the regulatory journey of pediatric mRNA COVID-19 vaccines from @PinkSheetHobbs:
https://t.co/zVj080OsfL

[Bowman Cox @bowmancox]

Bourla: Pfizer's other business units want to have "their own COVID moment."
https://t.co/2jMXMh6xHK

[Bowman Cox @bowmancox]

@SarahKarlin @KDooleyYoung @US_FDA The GAO report notes that the FDA only conducts pre-license or pre-approval inspections in 20% of instances.