We're still literally and figuratively ... Pink Sheet, Citeline Regulatory Michael McCaughan: Digging Through The US FDA Guidance Blizzard insights.citeline.com//pink-sheet/le…

This is interesting not just for drug development, but also for payers ... Pink Sheet, Citeline Regulatory Michael McCaughan: US FDA Guidance Redefines Obesity, But Keeps 2007 Efficacy Standard insights.citeline.com//pink-sheet/pa…

More thoughts on the acting FDA commissioner from Ramsey Baghdadi ... Pink Sheet, Citeline Regulatory: US FDA Acting Commissioner Pick Could Underscore Trump Team’s IT Focus insights.citeline.com//pink-sheet/ag…

US FDA And The ‘Move Fast And Break Things’ Government ow.ly/qNMX105YJTZ #PinkSheet

An interesting take on the current state of affairs from Michael McCaughan ... Pink Sheet, Citeline Regulatory: US FDA And The ‘Move Fast And Break Things’ Government insights.citeline.com//pink-sheet/le…

The irony ... Pink Sheet, Citeline Regulatory Michael McCaughan: The Kennedy Era At HHS Begins … With Two Vaccine Approvals insights.citeline.com//pink-sheet/va…

Taking a look at what layoffs could be coming next from Michael McCaughan and Ramsey Baghdadi ... Pink Sheet, Citeline Regulatory: DOGE-ing US FDA: Three Scenarios For What Comes Next insights.citeline.com//pink-sheet/ag…

Not sure industry would like this switch in agency thinking ... Pink Sheet, Citeline Regulatory Michael McCaughan: Turning Back The Clock At The US FDA insights.citeline.com//pink-sheet/ag…

The compounding lawsuits could have a bigger impact than just compounding GLP-1s. The U.S. FDA's drug shortage management could be at stake ... Michael McCaughan Pink Sheet, Citeline Regulatory: Compounding US FDA’s Problems: The High Stakes In GLP-1 Shortage Actions insights.citeline.com//pink-sheet/co…

Join us and Prevision Policy for #BioPharmaCongress: Ready for a New Era on 4/7. Key topics include the future of accelerated approval and how #AI guidance will be implemented in the real world. Register today: biopharmacongress.com

Amazing what a compliment can get you, our Michael McCaughan writes for Pink Sheet, Citeline Regulatory: Oz’s Magic: US CMS Administrator Pick Praises Staff, Unlike Other Trump Health Care Nominees insights.citeline.com//pink-sheet/ag…

Center director departures U.S. FDA used to be relatively rare. Maybe not anymore. From Michael McCaughan and Pink Sheet, Citeline Regulatory: US FDA Center Directors Are Political Now insights.citeline.com//pink-sheet/ag…

Despite saying U.S. FDA should be apolitical, the agency has done some seemingly political things since the new commissioner's arrival, Michael McCaughan reports for Pink Sheet, Citeline Regulatory: Political Influence And The US FDA: A New Era? insights.citeline.com//pink-sheet/ag…

Very proud and humbled to have JOHN LEWIS: A LIFE chosen as a finalist for the Pulitzer Prize in Biography. It was a privilege to write the life of this remarkable man, and it's been a joy to watch so many appreciative readers draw sustenance and hope from his story.

To say last week was "busy" for the U.S. FDA press corps. is an understatement ... Pink Sheet, Citeline Regulatory Michael McCaughan: US FDA Meeting Drought Ends … With A Vengeance insights.citeline.com//pink-sheet/ag…

Interesting that this is happening in the absence of more agency detail on the program ... Pink Sheet, Citeline Regulatory Michael McCaughan: US FDA ‘Commissioner’s Voucher’ As Public Relations Tool insights.citeline.com//pink-sheet/pa…

I bet Michael McCaughan has thoughts! This is a BFD, though we shall see what we see.

Best I can tell, these letters are already public as part of drug approval packages previously posted by FDA. So, maybe not such a BFD...

That would be a BFD, but not what FDA is doing here. These CRLs are I believe all already public.

Worth revisiting the new CDER Director's role in this meeting. via Michael McCaughan insights.citeline.com/pink-sheet/com…