Sue Sutter
pinksheetsutter.bsky.social
Sue Sutter
@pinksheetsutter.bsky.social
Senior Editor, Citeline's Pink Sheet, covering US FDA drug and biologic regulation and approvals. Views are my own.
Infants may receive a dose of hepatitis B vaccine before one month according to individual based decision-making.
September 18, 2025 at 12:07 PM
VOTE: The pediatric vaccine schedule should be updated to reflect the following change:
If a mother tests HBsAG-negative: The first dose of the Hepatitis B vaccine is not given until the child is at least one month old.
September 18, 2025 at 12:06 PM
For hepatitis B vaccine:

VOTE: All pregnant women should be tested for hepatitis B infection.
September 18, 2025 at 12:06 PM
Oh, this is gonna be a fun one, today.
May 22, 2025 at 1:17 PM
"I am very concerned," Makary writes. "Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth. Let’s be proactive in understanding and addressing the use of tianeptine products."
May 8, 2025 at 7:21 PM
Reposted by Sue Sutter
the thing that is being watched closely now is not just how much RFK inserts himself into FDA decisions but how much Makary and his commissioner's office inserts himself into certain decisions the commissioner's office also has traditionally stayed out of.
April 29, 2025 at 2:49 PM
Instead, FDA employees were encouraged to share with their children online information about the agency's work
April 24, 2025 at 2:58 PM