Advisory Committee Tracker: Opioid Meeting Rescheduled For Early May, Set To Be First Advisory Committee Of The RFK/Makary Era

Prevision Policy Clips | Makary Era At FDA Faces Tough Beginning: Marks’ Resignation, 3,500 Job Cuts Pending

FDA Disruption Accelerates: CBER’s Marks Resigns, Citing Vaccine Safety Disputes And Putting Gene Therapy Progress At Risk; Who Will Lead Product Reviews Under Makary?

FDA Guidance Could Be Key To Encouraging Studies Of “Indirect Benefits” From Infectious Disease Treatments; Regulatory, Payment Policy Could Help Uptake, Margolis Authors Suggest

Prevision Policy Clips | FDA Oncology Center Of Excellence Losing Top Deputies: Paul Kluetz And Marc Theoret

Career Staff Changes At FDA: Drug Review Division Deputies Left Or Moved In Early Months Of Trump II

FDA “Mission Is Unchanged,” Acting Commissioner Brenner Assures Staff; “Radical” Changes Coming, But Agency Will “Eventually” Be In “A Much Stronger Place”

FDA Facing Deep Job Cuts To Non-Review Functions Under HHS Reorganization Plan; IT, HR, Procurement, Comms – And Policy – Will Be Centralized At Department Level

Prevision Policy Clips | FDA Faces 3,500 Job Cuts In HHS Reorganization Plan, But Reviewers/Inspectors Will Be Spared

Prevision Policy Clips | The Makary Era At FDA Begins: Senate Confirms Martin Makary As FDA Commissioner

Prevision Policy Clips | FDA Deputy Commissioner For Operations/COO Is DoD Veteran Barclay Butler

Prevision Policy Clips | White Oak U-Turn: Senate HELP General Counsel Barrett Tenbarge To Remain With Committee, No Longer Headed To FDA

A Glow Up For VAERS? Rebranding Vaccine Safety Systems With More Robust, Community-Level Data Could Address Vaccine Hesitancy, Gottlieb Says

Prevision Policy Clips | “Most Favored Nation” Drug Pricing Options Outlined By GOP Think Tank

Vaccine Uptake Depends On “Compelling Evidence,” Not “Mandates,” FDA’s Marks Says; Planning Ahead May Make It Easier To Measure Indirect Benefits To Encourage Adoption

Prevision Policy Clips | Oz Faces GOP Stumbling Block On Road To CMS: Missouri Republican Sen. Hawley

Prevision Policy Clips | FTC Down To Two Commissioners After Trump “Fires” Democratic Commissioners

Prevision Policy Clips | “Newly Proposed” Benefits Is Focus Of ICER/NICE/Canada Drug Agency Working Group

Office Of Therapeutic Products Attempting To Weather Staff Cuts: “We’re Going To Do Our Best,” CBER Director Marks Says

Prevision Policy Clips | Return-To-Office Day For FDA: Expect Disruptions

CMS Nominee Oz Delivers Wizardly Performance In Confirmation Hearing; Drug Pricing Is Not Major Focus, But Oz Pledges To Use Price Negotiation, Support Sickle Cell Demo

Prevision Policy Clips | Flu Strain Selections Announced By FDA After Internal Meeting

FDA Rare Disease “Case Studies” Illustrate Dose Optimization (Sanofi’s Xenpozyme) And Single Trial Efficacy Standard (Sentynyl’s Nulibry)

FDA Commissioner Nominee Makary Clears Committee After Chief Counsel Departs; CDC Nominee Weldon Withdrawn By White House

Prevision Policy Clips | FDA Reverses Course On Chief Counsel Ahead Of Makary Confirmation Vote: Hilary Perkins “Has Resigned