Prevision Policy Clips | COVID-19 Vaccination Removed From Vaccine Schedule For Healthy Children And Pregnant Women

COVID Vaccine 2025-2026 Formula Will Be JN.1 Lineage, With Preference for LP.8.1 Strain: VRBPAC Members Question Impact of New Framework on Availability; FDA Has No Answers

Prevision Policy Clips | Biopharma CEOs Invited To Engage With FDA Leadership

UroGen’s Bladder Cancer Mitomycin Gel Gets ODAC Split Vote; FDA Expresses Concern About Low-Bar Precedent From Single-Arm Trial

FDA Talc Talk: “Expert Roundtable” Urges Cautious Approach on Talc – And Illustrates Echo-Chamber Regulatory Approaches Under Makary; Pharmaceuticals Have Largely Moved to Alternative Excipients

Prevision Policy Clips | FDA Advises COVID Vaccine Manufacturers To Use JN.1 Lineage With Specific Strain After Unanimous VRBPAC Vote

Drug Reviews Are “On Time,” FDA’s Makary Testifies; Missed Goal Dates Are Due To “Complexity,” Not Cuts; Proposed 11.5% Budget Cut “Will Not Fly,” Sen. Murray Declares

Organ-On-A-Chip: FDA “Roadmap” Doesn’t Clear All Obstacles For Animal Testing Alternatives, GAO Report Says; Upcoming Guidance Could Help, But Timeline Uncertain

OCE’s Pazdur Sinks Pfizer’s Talzenna In “All Comers” Prostate Cancer; New Trial Needed For “Huge” Indication Expansion

Prevision Policy Clips | FDA Acting OII Director Is Elizabeth Miller

J&J Darzalex Faspro Use In Smoldering Myeloma Supported By ODAC Despite Reservations About Over-Treatment; Will FDA And Sponsor Agree On “High Risk” Claim?

FDA Offers More Support For States Who Want To Import Drugs From Canada; “Pre-SIP” Meetings, Feedback In Fall Among Plans

Prevision Policy Clips | Trump Administration “In Negotiation” With Drug Companies Over MFN

FDA’s Two-Tier COVID “Framework” Unveiled: RCTs Required To Support Boosters In Young, Healthy Individuals, But Policy Does Not Extend To Other Vaccines

Columvi STARGLO Supplement Shot Down By ODAC; FDA Will Be Pressing Sponsors To Choose Optimal Control Arms For US Patients In Global Trials

MFN 2.0: HHS Sets Pricing Target To Lowest Price In An OECD Country; Trump Administration Wants Manufacturer Commitments “In Coming Weeks”

COVID Booster Meeting: FDA Releases Bare Bones Briefing Document Ahead Of May 22 VRBPAC; New “Framework” Mandates Randomized Trials In Future

The Makary Moment? FDA Commissioner, CBER’s Prasad Make Brief Appearance At ODAC Review Of Genentech’s Columvi

Prevision Policy Clips | FDA COVID Vaccine Framework Will Be Unveiled At 1 PM

Urogen UGN-102 ODAC Review Stems From FDA’s Preference For Randomized Trial In Low-Grade Bladder Cancer; Novel Mitomycin Formulation Role Versus TURBT Is Key Topic

FDA AI Policy In Flux: Draft Guidance Should Not Be Viewed As Reflecting Current Agency Views, Former HELP Staffer Advises

FDA Commissioner Makary’s PR Push Starts With Public Roundtable Series: HRT, Talc Are Initial Topics; Vaccine “Framework” Coming From CBER’s Prasad

PDUFA VIII Predictions: AI, Domestic Manufacturing Policies May Be Focus; Anti-Regulatory (And Anti-Industry) Administration May Make For Smaller Program

Prevision Policy Clips | FDA Commissioner Makary’s First Appropriations Hearing Set For May 22

Pfizer Faces Skeptical FDA For Talzenna “All Comers” Prostate Cancer Indication, But Can ODAC Say No To Survival Benefit?