PDUFA VIII: Commissioner Makary Suggests Lower Fees Could Be One Goal, CEO “Listening Tour” Starts Focus On Communication, Predictability

Prevision Policy Clips | Commissioner’s Voucher As Incentive For Price Reductions? FDA Commissioner Makary

GDUFA IV Gets Underway: Makary Highlights Supply Chain Improvements During Kick-Off Meeting; Industry Asks For Continued Focus On Complex Generics

Remote Regulatory Assessments: FDA Clarifies That “Mandatory” RRAs May Still Include “Voluntary” Requests In Final Q&A Guidance

Prevision Policy Clips | Senate Appropriators Advance Flat FDA Funding For FY 2026: Improvement On House Version

FDA Posts Past Rejection Letters To Centralized Database For Approved Products; Non-Disclosure Policy For Unapproved Applications Remains In Place

FDA Pediatric Advisory Committee Member’s Call For Enhanced Monitoring Of Adverse Event Reports May Resonate With New Leadership

Prevision Policy Clips | FDA Makes Access To Already Public Rejection Letters Easier

Myelodysplastic Syndrome: FDA Affirms Viability Of Transfusion Independence As Efficacy Endpoint; Guidance Is First New Drug Development Advice Of Makary/Trump Era

Prevision Policy Clips | Senate FDA Appropriations Mark-Up Set For July 10

Reducing Animal Testing: New Biologics Pathway Modeled On 505(b)(2) Could Help, FDA Staff Tell Commissioner; Workshop Follows “Roadmap” On Alternatives To Animal Testing

FDA AI “Opt-In”? Agency May Ask Sponsors For Permission To Train AI Models Using NDA/BLA Data; Alternatives To Animal Testing Could Be Test Case

RTOR Tracker: FDA “Real Time” Review Use Picked Up In 2024 As Interest In Expansion Outside Oncology Increases

Prevision Policy Clips | Ending Animal Testing: FDA May Ask Sponsors For Permission To Train AI

Prevision Policy Clips | HR 1 Signed Into Law: Orphan Drug “Negotiation” Exemption Expanded, But Long Term Impact On Insurance Coverage

FDA Deadline Tracker: KalVista Miss Is Big News In June, And Uncertainty Spikes With Ongoing Leadership Departures

Prevision Policy Clips | Nuvaxovid, mNEXPSIKE Approval Memos Confirm CBER Director Prasad’s Role In Restricting Indication

Prevision Policy Clips | Orphan Drug Incentives Get Through Senate, House Vote Expected Today On Reconciliation Bill

Prevision Policy Clips | FDA To Require Labeling Revision To All ADHD ER Drugs For Weight Loss Risk In Children Under Six

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 | FDA Eliminates REMS, Loosens Patient Monitoring Requirements For CAR-Ts

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