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FDA Commissioner Nominee Makary Clears Committee After Chief Counsel Departs; CDC Nominee Weldon Withdrawn By White House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

FDA Gene & Cell Therapy Office Leadership Ranks Are Thinning Fast: Office of Clinical Evaluation Director Fashoyin-Aje, Cell Therapy CMC Head Lombardi Are Latest Departures

Prevision Policy Clips | FDA Chief Counsel Will Be Hilary Perkins After HHS Reorganizes

Makary’s Team Takes Shape: FDA Deputy For Legislation Is Former Hill Staffer With User Fee/21CC Experience Graham; Chief Of Staff Is Traficant

Flat-Line Funding Is Best Case For FDA Heading Into Shutdown Uncertainty, Return-To-Office Deadlines; Pediatric PRV Still In Limbo

Prevision Policy Clips | FDA Medical Reviewers, Manufacturing Inspectors Not Eligible for HHS “Buyout”

Prevision Policy Clips | CMS Nominee Oz Set For Confirmation Hearing March 14