Jamie Singer
@jswatercooler.bsky.social
Regulatory Affairs Professional. Accelerating drug development since 1996.
Reposted by Jamie Singer
🧪This is how global collaboration of science is supposed to work.
Via @sciencestories.bsky.social on IG
Via @sciencestories.bsky.social on IG
December 13, 2025 at 2:15 AM
🧪This is how global collaboration of science is supposed to work.
Via @sciencestories.bsky.social on IG
Via @sciencestories.bsky.social on IG
This is shocking news, potentially destabilizing the industry
Updated FDA org chart from BioSpace: nearly 90% of sr leaders who were at FDA a yr ago are gone. Most FDA employees are usually "career staff" who worked 4 multiple FDA commissioners & yrs of training 2b knowledgeable incl cell & gene therapies. Pazdur had worked 4 Bush, Obama,Trump & Biden #medsky
December 10, 2025 at 5:22 PM
This is shocking news, potentially destabilizing the industry
Reposted by Jamie Singer
A spokesperson for the FDA's parent agency, HHS, spoke with Reuters & confirmed the story. HHS's spokesperson wasn't able to give a medical reason for why the FDA opened new "safety" investigations into all 3 FDA-approved RSV therapies. #medsky
The US became the only known country to have new regulators opening "safety" investigations into FDA-approved RSV therapies. AstraZeneca, Merck & Sanofi received letters last week & HHS confirmed w/Reuters. This comes after Rick Pazdur resigned from FDA's CDER www.reuters.com/business/hea... #medsky
December 9, 2025 at 9:12 PM
A spokesperson for the FDA's parent agency, HHS, spoke with Reuters & confirmed the story. HHS's spokesperson wasn't able to give a medical reason for why the FDA opened new "safety" investigations into all 3 FDA-approved RSV therapies. #medsky
Reposted by Jamie Singer
Reposted by Jamie Singer
A landmark new study in JAMA Pediatrics shows the HPV vaccine is doing exactly what it promised & more. 17yrs after rollout, adolescent vaccination has slashed HPV infxns not only among those vaccinated but also those unvaccinated, showing powerful herd protection.
jamanetwork.com/journals/jam...
jamanetwork.com/journals/jam...
Population-Level Effectiveness and Herd Protection 17 Years After HPV Vaccine
This cross-sectional study investigates population-level effectiveness and herd protection in the first 17 years after human papillomavirus (HPV) vaccination among adolescent girls and young women at ...
jamanetwork.com
September 30, 2025 at 3:39 PM
A landmark new study in JAMA Pediatrics shows the HPV vaccine is doing exactly what it promised & more. 17yrs after rollout, adolescent vaccination has slashed HPV infxns not only among those vaccinated but also those unvaccinated, showing powerful herd protection.
jamanetwork.com/journals/jam...
jamanetwork.com/journals/jam...