Prevision Policy Clips | DOGE Phase 2: OMB Guidance Calls For Agency RIF And Reorganization Plans (ARRP) By March 13

Cell Therapy Regulatory Revamp Could Mirror Device Regulations: A Risk-Based System Would Encourage Development And Discourage “Bad Actors,” CBER Says

Prevision Policy Clips | FDA Shutters Clozapine REMS

FDA Drug/Biologic Review Largely Insulated From DOGE RIFs So Far; Communications Freeze (Sort Of) Lifted

GLP-1 Pushback? HHS Inspector General Flags Surging Use Of Anti-Diabetics, Suggests Scripts May Be Outside “Medically Accepted Indications”

Prevision Policy Clips | CBER’s Marks And Verdun Deliver Opening Remarks At HCT/P Workshop

House Energy & Commerce Committee Plans To Highlight Downsides Of Price Negotiation In 119th Congress; Domestic Manufacturing, Chronic Diseases Among Other Topics On Oversight Agenda

Prevision Policy Clips | Medicare Price Negotiation: CMS Sets Dates For Roundtable, Town Hall Events

FDA Retirements And Departures: CDER Changes Include Departures Of Pain Medicine, Non-Malignant Hematology Division Leaders; CBER Deputy Witten Has Retired

Prevision Policy Clips | Vaccine Disruption Begins: ACIP Meeting Postponed

Medicare Adds Former Trump I Official Aramanda As Principal Deputy Director; Former OMBer Albanese Is Policy Advisor

Prevision Policy Clips | CBER Gene/Cell Therapy Leadership Team Appears Set For First Public Presentations Of Trump Era

Make HHS Anti-Industry Again? Kennedy Blames “System, Not The People,” For “Inefficient, Dysfunctional Or Corrupt” Agencies In First Address To Staff

Prevision Policy Clips | Disrupting FDA: Agency Managers Unsure Of Who Is Laid Off Until Notified By Affected Staff

Prevision Policy Clips | FDA Layoffs Begin: Device Center Appears More Affected In Round One

The Kennedy HHS Era Begins With FDA Staff On Edge: “MAHA” Commission Launches With Anti-Industry Themes – But Better Than Some Alternatives

Prevision Policy Clips | HHS Secretary Kennedy Defuses Rumors Of 50% Cuts In Staff, But Leadership Purge

White House Supports Shutdown Model For DOGE Cuts; Musk Says Cuts Will Be Made “In Partnership” With Agency Heads; UCSF’s Prasad Rumored To Be Seeking FDA Role

FDA RMAT Designations Spiking: Agency Granted 43 Requests In FY 2024 And Nine More In First Quarter Of FY ‘25; RMAT Approvals Now Total 13

Prevision Policy Clips | FDA/NIH Rare Disease Still On For February 27-28, With Key FDA Officials On Agenda

HTA Harmonization? ICER Teams Up With British NICE and Canada’s Drug Agency To Form Partnership To Assess New Health Economics Methods

Prevision Policy Clips | DOGE Layoff Order Unveiled, But No Targets Set For FDA

The End Of The User Fee Era? DOGE, Budget Cuts Could Undo Core FDA Regulatory Model

AI Regulation At FDA May Drive Drug/Device Regulatory Convergence; Guidance Development Highlighted As Key For Field At FOCR Meeting

Prevision Policy Clips | FDA Warns Of Medication Errors With Tranexamic Acid Injections, Opens Investigation