One wonders if the US COVID-19 vaccine stockpile will outlast vaccine hesitancy as the Delta variant surges. Expiry extensions based on continuing stability testing may help: pink.pharmaintelligence.informa.com/articles/2021/…

This is turning into an increasingly challenging issue. US FDA Won't Budge On Nitrosamines Compliance Despite Complaints Of Possible Drug Shortages pink.pharmaintelligence.informa.com/articles/2021/…

#CDC on why masks are back for the vaccinated: cdc.gov/mmwr/volumes/7….

Just because FDA can detain imports from red-listed pharmaceutical suppliers at the border doesn't mean it will, necessarily. pink.pharmaintelligence.informa.com/articles/2021/…

An international approach to flagging falsified medicines is emerging but questions remain about who will pay for it, @ScripIanS reports: How To Set Up A Medicines Traceability System pink.pharmaintelligence.informa.com/articles/2021/…

A fascinating look from Ian Haydock at the politics around #Taiwan's surprisingly efficacious #COVID19 #vaccine: scrip.pharmaintelligence.informa.com/articles/2021/…

More from Derrick: Could Sponsors’ Supply Chain Policing Have Caught Alleged CRO Fraud? pink.pharmaintelligence.informa.com/articles/2021/…

Bourla: Pfizer's other business units want to have "their own COVID moment." pink.pharmaintelligence.informa.com/articles/2021/…

A dose of reality on the regulatory journey of pediatric mRNA COVID-19 vaccines from Nielsen Hobbs: pink.pharmaintelligence.informa.com/articles/2021/…

if someone had told me in 2014, when I did not know what FOIA was, that Nieman Lab 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. niemanlab.org/2021/11/journa…

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 medtech.pharmaintelligence.informa.com/articles/2021/…

BARDA Lays Out Vision For Next Pandemic: Vaccines For The US Within 130 Days pink.pharmaintelligence.informa.com/articles/2021/…

#FDA has caught up on OAI follow-up #inspections, Shannon Brown reports. pink.pharmaintelligence.informa.com/articles/2021/…

When a story like this comes along, I can't help but wonder what WEEKLY WORLD NEWS would have done with it. tmz.com/2022/03/24/par…

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

The commish Dr. Robert M. Califf on the upcoming retirement of Dr. Janet Woodcock from U.S. FDA

The latest Pink Sheet, Citeline Regulatory podcast is posted! Listen to Nielsen Hobbs, Bowman Cox and I discuss the AAM conference, FDA under Trump 2.0, and Hill hearings on drug shortages and foreign inspections #pinksheet #pharma: soundcloud.com/citelinesounds…