Bristol’s Persistence In Pursuing Breyanzi NTAP Wins CMS Acceptance For Two Indications; CMS Grants Seven New Drug Add-On Payments For FY2026

Prevision Policy Clips | HHS Ends mRNA Vaccine Development Under BARDA: "No New mRNA-Based Projects Will Be Initiated"

RWE In 2025: Focus Should Be On “Methodologic Expertise,” Transparency Measures; Some Stakeholders Call For Updates To FDA Guidances

Prevision Policy Clips | FDA Chief Counsel Is Sean Keveney

FDA Deadline Tracker: A “Record Year” For NMEs? Commissioner Makary Aiming High Despite Ongoing Turmoil At The Agency; Other Deadlines May Suffer

Prevision Policy Clips | FDA And CRLs: Prevision Policy Analysis of 283 Letters Shows Adverse Inspection Findings

Opioid Safety: FDA Requiring Class Labeling With Risks Seen In Observational Studies; Adcomm Had Cautioned Against Incorporating Specific Data

FDA’s CRLs By The Numbers: Inspections, Product Quality Are Most Common Reasons For Rejections; 505(b)(2) NDAs Dominate First Batch Of Letters Released By Agency

Prevision Policy Clips | Trump Repeats MFN Threat; Gives Companies Another 60 Days

Prevision Policy Clips | Pilot Testing A Single Center? CDER Director Tidmarsh Will Serve As CBER Acting Director

FDA Project Orbis Up To 118 Approvals; “Project Nozomi” Will Facilitate Submissions In Japan; Pazdur Makes Plug For Expanding To Other Therapeutic Areas

Rx-To-OTC Switch Framework Provisions Added To OMUFA Reauthorization In Senate: FDA Would Identify Switch Candidates And Work With Sponsors

CBER Reset After Prasad Departs FDA: Setback For Commissioner Makary’s Agenda Means Still More Uncertainty For Cell/Gene Therapy Reviews

Prevision Policy Clips | Disruptor Disrupted: CBER Left Leaderless And Depleted Following Abrupt Exit Of Director Vinay Prasad

Advisory Committee Tracker: No Panels Currently Scheduled, As FDA Leadership Clearly Prefers Other Options; Elevidys Back And Forth Is Case In Point

User Fee Rate Updates: Biosimilar Fees Decline Thanks To Operating Reserves; PDUFA Fees Climb About 9%, ANDA Fee Jumps 11%

Prevision Policy Clips | Sarepta Elevidys Reversal: FDA Lifts Hold For Ambulatory DMD Patients

Prevision Policy Clips | EU Trade Deal Includes 15% Tariffs On Brand Pharmaceuticals, "Certain Generics" Excluded

“All-Interchangeable” Biosimilar Policy Gains More Support In Drug Pricing Debate; FDA Says Proposal Is Aimed At “Simplifying” Pre-Market Expectations

Prevision Policy Clips | CBER Gene/Cell Therapy Office Listening Session On “Leveraging Knowledge” Set For Sept. 18

CDER Highlights Successes Of Selective Safety Data Collection In White Paper; Signal That Push Toward “Pragmatic” Trials Will Continue In New Era At FDA

Prevision Policy Clips | CDER White Paper On Selective Safety Data Collection

Prevision Policy Clips | CDER Director Tidmarsh Praises “Quality And Integrity” Of FDA Staff

FDA “Commissioner’s Voucher” Program Open For Submissions; CMO Prasad Will Lead Dedicated Review Team For Each “Winner,” Providing MFN Pricing Is One Way To Qualify

FDA Select Panel Questions Use Of SSRI Antidepressant Class In Pregnancy, Airs Arguments Against Pharmaceuticals For Depression In General