Rare Disease Data Sharing Research Agreements Could Be “Normalized” Through Financial Incentives; FDA’s “Plausible Mechanism” Guidance Is A Positive Step

Prevision Policy Clips | “Plausible Mechanism” Draft Guidance Is “Big Catalyst” For Encouraging Data Sharing

Reagan-Udall Rare Disease “Regulatory Agility” Report Proposes Evidence Framework For Slowly Progressive Diseases; Opportunities Identified For AI

FDA Deadline Tracker: “Flexibility” Makes A Comeback – At Least In FDA Press Releases; Positive Short-Term Signs In March Approvals, But Long-Term Uncertainty Remains

“America First” User Fees Are A Go: Industry Supports Half-Fees For Products First Studies In US In PDUFA VIII; Says FDA Use Of Fees For RIFs “Undermined” Program

Prevision Policy Clips | Digital Health Technologies In Clinical Trials RFI Seeks To Build On 2023 FDA Guidance With A Digital Endpoints Workshop A Possibility

Nonprescription Drugs, ACNU Pathway Intersect With Conversation Around Advancing Over-the-Counter Diagnostics; “Wellness” Guidance

Advisory Committee Tracker: ODAC Is Back, With Two AZ Applications Set For Review April 30 Including Potential ctDNA Milestone; Still No Others On FDA’s Agenda

Prevision Policy Clips | “Pazdur Direct” Is Former OCE/CDER Director Richard Pazdur’s Consulting Firm

Prevision Policy Clips | Denali Avlayah Approval Based On HS Biomarker Comes After Long FDA Process

FDA Advisory Committee Conflicts Of Interest Draft Guidance Coming: Agency Pledges To Publish Explanation Of Financial CoIs In Response To GAO Report

Prevision Policy Clips | FDA Promises Guidance On Advisory Committee Conflict-Of-Interest Procedures

FDA’s “America First” User Fee Push Continues; Some Premarket Proposals Finalized In PDUFA VIII Talks; Industry Concerned By Spending Increases Despite RIFs

Thin Industry Margins And Staff Losses At FDA Preclude Need For GDUFA Fee Restructuring, Industry Says In Negotiations

Prevision Policy Clips | FDA Gene-Editing Draft Guidances Received By OMB

Project Orbis Approvals Have Slowed Modestly In Trump Administration; Three Approved So Far in 2026, 132 Since OCE Global Partnership Launched In 2019

Prevision Policy Clips | Non-Opioid Pain Drug Coverage Would Be Boosted In Part D By House Bill

CNPV Feedback Meeting Set By FDA For June 12: “Part 15” Hearing Announced In Wake Of Novo Wegovy HD Approval; How Will First Overtly “Political” Voucher Play?

Prevision Policy Clips | CNPV Feedback Meeting Set For June 12: “Part 15 Hearing”

China Threat Remains Bipartisan Theme Heading Into PDUFA Reauthorization: Congress May Knit Together Essential Medicine And “First-In-Human” Biotech Trial Provisions

Prevision Policy Clips | CDER Departures Continue: Infectious Disease Office Director Sherwat Is Leaving The Agency

Seeking Validation: FDA New Approach Methodologies “General Considerations” Guidance Outlines Validation Framework As Part Of Push to Reduce Animal Testing

Industry “Tentatively” Agrees To Increase Foreign Facility Fee Differential In GDUFA Negotiations; Program Fee Restructuring Is Key Area Of Disagreement

Most Favored Nation Codification Bill Would Give White House Leverage To Force Pricing “Deals” With All Manufacturers; Enactment Unlikely

Prevision Policy Clips | CBER Clarifies Clinical Hold-Related Policies For RMAT Designated Products