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”

FDA’s Next DOGE Test: How Will “Maximum” Cuts Be Defined For Agency Under OMB Memo Implementing Trump Executive Order

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