FDA In 2026: A More Cautious Agency Is Emerging

Prevision Policy Clips | Orphan Drug Incentives Survive Senate Reconciliation Bill, PBM Reforms Do Not

Prevision Policy Clips | Friday, June 27, 2025

ACIP Votes To Remove Thimerosal From Flu Vaccines: Commercial Impact In US Is Negligible, But Disruption From Reconstituted Panel May Be Just Starting

ACIP Panel Signals Key Topics For Future Work Group Presentations: In-Depth Analyses Of Deaths, Adverse Events Included

Kennedy’s ACIP Takes First Steps Toward Altering Childhood Vaccine Schedule With Establishment Of New Work Groups

Prevision Policy Clips | FDA Says Final Antibiotics Guidance Is “Deregulatory In Nature,”

Psychedelic Drug Development Prioritized At FDA, Kennedy Says At House HHS Budget Hearing; MFN Price Negotiations “Very Complex” And Ongoing

CDC Nominee Monarez Dodges Questions About ACIP Membership, But Confirms Importance Of Vaccines During Senate Confirmation Hearing

Prevision Policy Clips | Usona Institute CMO Mike Davis Named CDER Deputy Director; Former FDAer

Real-World Evidence Submissions To FDA: Three Product Applications Used RWE In FY2024

Prior Authorization Reform Pledge: Insurers Will Have “Real-Time Responses” For 80% Of Electronic Requests By 2027; HHS Applauds Voluntary Approach, Stresses Interoperability

Prevision Policy Clips | CDER’s Corrigan-Curay Announces Retirement As New Director Announcement Appears Imminent

Advisory Committee Tracker: Rexulti For PTSD And Blenrep’s Return Highlight FDA’s July Agenda – But Capricor DMD Therapy Vanishing Act May Be Biggest News

Prevision Policy Clips | House Appropriations Committee Will Resume FDA Funding Mark-Up Tonight

FDA Highlights Standardized Safety Data Presentation Tools Via MAPPs And New Website, Cites Potential To Streamline Reviews; Guidance By Other Means?

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened Scrutiny, FDA Says; No Disruption To Ongoing Treatment, But New Trials Must Have “Domestic” Handling

Prevision Policy Clips | FDA Cell And Gene Therapy Review Office Will Be Led By Vijay Kumar

Sanofi’s Tolebrutinib For Multiple Sclerosis Could Find “Niche” Market Among Established Drugs; Liver Monitoring Likely A Barrier To Uptake, ICER Panel Says

Cell And Gene Therapy Regulatory Uncertainty Spikes: OTP Director Verdun, Deputy Anatol Forced Out; Will Prasad’s New Role As “CMSO” Mean More FDA Disruption Ahead?

Fastest Reviews At FDA: “Commissioner’s Voucher” Timeline Is Not Unprecedented; Two Dozen NMEs Have Been Approved In Less Than Four Months – Since 1985

Prevision Policy Clips | HHS Budget Hearing In House Energy & Commerce/Health Subcommittee June 24

America First: “Commissioner’s National Priority Voucher” Promises “1-2 Month” Review For Select US Firms; Criteria Uncertain – As Are Potential Benefits

Prevision Policy Clips | Senate Reconciliation Bill Drops Orphan Drug Price Negotiation Fix

FDA Asked To Explain Apparent Increase In NDA Rejections By House Appropriators; COPD, DMD, HIE Among Diseases Highlighted For Special Attention In Approps Report