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.U.S. FDA keeping a "firewall" between COVID-19 review staff at center for biologics and "Operation Warps Speed," BARDA operatives, CBER's Marks says. FDLI

JUST ANNOUNCED: FDA Oncology's Pazdur will participate in a fireside chat for Day 1 of our Annual Meeting (11/13). FDA Biologics's Marks & FDA CDER's Cavazzoni will have a fireside chat moderated by Prevision Policy's Kate Rawson Powell on Day 2 (11/19). #FriendsAM20 #WhatFriendsDoes

Great interview with Hopkins’ Josh Sharfstein, a possible Biden pick for FDA Commissioner. All about protecting FDA’s integrity from politics. Discussed the perceived pendulum swing between safety and efficacy. Plus, yellow room is AWESOME.

Biden becomes President elect and two days later, #PFE announces 90% efficacy with their COVID vaccinE. Coincidence? Doubtful. #thanksJoe #2021lookingbetteralready

#BidenHarris #healthpolicysquad Start placing your bets....

Watching #ChristmasChronicles 2 with the fam and the Christmas Star looks a lot like the #coronavirus spike protein.

Authorizes. Not approves. I’ve been forcing this distinction down everyone’s throat since the beginning of the pandemic. Will I ever get over it? Unlikely. #healthpolicy U.S. FDA #vaccines

COVID vaccine appointment for my 13 year old confirmed for Saturday. What???? Thank you, Maryland Fairgrounds and Governor Hogan for being so on top of this! marylandvax.org/appointment/en… #GoVAXMaryland Gov. Larry Hogan

This was a fun interview, as always, with Rick Pazdur. Thanks to #TheCorona, we are now adept enough at Zoom to record this latest chat on camera, rather than a muffled audio over speaker phone from my closet.

Finance Chair Wyden says “authoritative sources” have told him Biden will name his pick to lead FDA soon.

Credit also to the apparently multi-talented Nielsen Hobbs for the incredible visual that accompanied this article.

And our Kate Rawson Powell looks at the U.S. FDA FDA CDER director's comments: Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says pink.pharmaintelligence.informa.com/articles/2021/…

Briefing docs up for $PFE #COVID19 #boosters meeting on Friday, but no U.S. FDA documents and no voting questions. An oversight? Or something more? Refresh, refresh, refresh....

FINALLY!

Woodcock says she's transitioning to Principal Deputy ->

After two years waiting for U.S. FDA to figure out #audioissues during #VRBAC meetings, I can now easily hum along to each piece of hold music.

Telling a stranger how often you did or didn't get COVID is approximately as interesting a conversation as telling a stranger about your fantasy football draft.

Looking forward to moderating at Friends of Cancer Research’s Public Meeting “The Future of Diagnostic Tests: New Data & Modern Policy” Thursday, Feb. 1st, 2024 from 10:00AM - 2:30PM ET. Click to register here: bit.ly/3t7MYZ3 #AIOncology #FriendsDx #HRDFriends