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FDA Commissioner Nominee Makary Clears Committee After Chief Counsel Departs; CDC Nominee Weldon Withdrawn By White House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

ICER Panel Endorses Value Of Vertex’ Journavx Compared To Opioids, But Questions Benefits Compared To NSAIDs; Coverage Policies Will Be Key To Uptake

Prevision Policy Clips | FDA Commissioner Nominee Makary Breezes Through Senate Hearing

VRBPAC Will Be Back, But Maybe Not For Flu, FDA Commissioner Nominee Makary Says; Is Another Advisory Committee Reset Coming?

Generics, Biosimilars – And OTCs – Are Part Of FDA Role In Drug Pricing Policy, Commissioner Nominee Makary Says

FDA Nominee Makary Promises “Surgical” Approach To FDA Cuts – But No Guarantee He Will Be Wielding The Scalpel; “MAHA” Themes Coming To FDA, But Toned Down From RFK

Prevision Policy Clips | Trump’s 10-To-1 Deregulation Policy Will Force FDA To Give “Care And Consideration”

Drug Pricing, Researcher Conflicts Of Interest With Big Pharma Get Attention During NIH Nominee Bhattacharya’s Senate HELP Confirmation Hearing

Prevision Policy Clips | Trump Praises MAHA Commission, Announces “Reciprocal Tariffs” On April 2

Prevision Policy Clips | Drug Prices, Pharma Tariffs And Medicaid Cuts Are Topics To Watch For During President Trump's Address

Prevision Policy Clips | FDA Return To Office Procedures Are Underway; Initial Process Is Relatively Smooth

Controlled Correspondence: FDA Encourages Generic Sponsors To Ask Better Questions; SBIA Event Includes Plea For Industry To Affirm Value Of FDA Public Meetings

FDA Deadline Tracker: No Sign Of Slippage On Drug Reviews In First Month Under Trump

Prevision Policy Clips | FDA Commissioner Nominee Makary Set For March 6 Confirmation Hearing

Advisory Committee Tracker: FDA Resumes Public Speaking Engagements – But Advisory Committees Still MIA

PRV Renewal, PBM Reform Are Bipartisan Issues At House Health Subcommittee Hearing But Pathway Is “Uncertain”