FTC/DOJ On Drug Pricing: “Balance” Needed Between Patent Rights And Reforms; USPTO Warns Against Overregulation In Final Listening Session

Prevision Policy Clips | Vinay Prasad’s Return To FDA: Move Signals Continued Volatility At Agency; A Fragile Stability Could Be Best-Case Scenario

Prasad’s Return To FDA Puts Center Consolidation Plan On Back Burner (Again), But Does A Window Remain Open For OCE 2.0?

Makary’s Prodigal Son Returns: Prasad’s Rebound At FDA Underscores Continued Volatility At Agency; Will A Fragile Stability Emerge?

Prevision Policy Clips | FDA Commissioner Makary On Lessons Learned From CEOs: "They Want Better Communication"

FDA “PreCheck” Domestic Manufacturing Proposal Features Pre-Operations Phase 1, Phase 2 To Offer “Advanced Awareness” Of Strategies For Specific Drugs

Prevision Policy Clips | Onshoring Drug Manufacturing: FDA To Present “PreCheck” Framework At Public Meeting Sept. 30

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