Saving Part D: MedPAC Debates Ways To Make Stand-Alone Plans More Viable; Warns That Future Of Traditional Medicare May Be At Stake

Fixing Biosimilars: Stelara Will Be Test Of Price Negotiation Impact; FDA Cuts May Have Significant Adverse Effect At Tough Time For Sector

“A Slow Moving Catastrophe”: FDA Layoffs Will Result In Less Guidance And Less Flexibility, Ex-Leaders Suggest; Cell/Gene Therapy Could Be A Bright Spot

Prevision Policy Clips | Digital Health Technologies In Clinical Trials: FDA Viewpoint Posted In JAMA

FDA “Five-Office” Reorg Proposal Criticized By Former Senior Officials; Regulatory Work Is Too Specialized For A “Big Team Of Generalists”

RFK At FDA: “Dissidents Will Be Listened To,” HHS Secretary Kennedy Says; Commissioner Makary Calls For “More Teamwork,” Less “Individual Empires”

Prevision Policy Clips | FDA Animal Testing Alternatives “Roadmap” Sets Three-Year Agenda

FDA To Phase Out Animal Testing For Monoclonals, FDA Commissioner Makary Says; Pilot Test In 2025 Aims To Lead To Broader Changes As “NAM” Process Moves Forward

HHS Drug Shortage Policy Reset: Trump Administration Urged By GAO To Focus On Coordination At Department Level; Report Provides Update On FDA Activities As Of 2024

Prevision Policy Clips | GLP-1 Agonist Coverage In Medicaid/Medicare: “Regulatory Framework” Still Under Consideration

FDA Rare Disease “Hub” Is Moving Forward With Agenda To Improve Consistency And Coordination Amid Agency Changes

FDA Oversight Of Compounded GLP-1 Products Urged By Former Commissioner Kessler In House Hearing On “Illicit” Products

FDA Generics Office Urges Renewed Focus On Data Integrity At Annual Update Meeting; Speakers Demonstrate Commitment To GDUFA Goals Amid Restructuring

Prevision Policy Clips | Hybrid Work Returning For FDA Reviewers?

House E&C Leadership Commits To Seeing PBM Reform Through; Other Health Measures Must Garner Similarly Strong Bipartisan Support

Prevision Policy Clips | “A Slow Moving Catastrophe”: Ex-FDA Leaders Paint Dark Picture

Prevision Policy Clips | CMS Drops Obesity Drug Coverage Proposal From Final Part D Update Rule

PBM Reforms Remain Live Topic On Capitol Hill While FTC Chaos Stalls Insulin Case

Imagining A Five-Office FDA: HHS Reorg Plan Could Merge All Product Centers Into One; Enforcement, Policy, Strategy, Admin Would Be Other Four

Prevision Policy Clips | Concepts Of A Plan? FDA “Streamlining” Will Result In “Five Shared Services Offices,” HHS Says

Generic Drug Competition/Patent Bills Still Have Bipartisan Backing In The Senate; Product “Hopping” And “Sham” Petitions Are Not Unanimous In Judiciary Committee Mark-Up

FDA Cuts May Impact Complex Generic Reviews, Inspections Despite Intent To Keep Applications Moving, Former Commissioner Gottlieb Says

Prevision Policy Clips | Novavax COVID Vaccine BLA Poses Early “Test” For Commissioner Martin Makary

Makary Introduces Himself To FDA Staff: “Our Country Needs You…I Will Do My Best” To Assure Resources; COVID Response Critic Hoeg Joins As Special Advisor

MAHA Vision For FDA Includes New Pathways For “Root-Cause” Treatments, But Not Traditional Big Pharma; HHS Advisor Means Says Layoffs Reflect “Failure” Of Agencies