Prevision Policy Clips | OTC Monograph User Fees For FY 2022: FDA Anticipates Budget Of Roughly $22 Mil.

User Fee Ride Along Candidates: House Hearing Will Consider Almost Two-Dozen Rx Bills; CURES 2.0 Is Centerpiece, But What Else Makes The Cut?

OCE’s Pazdur Makes It Personal On Dose Optimization During OCE Patient Tolerability Discussion

Prevision Policy Clips | User Fee Ride-Along Candidates: House Hearing Includes Array Of 22 Bills

Prevision Policy Clips | “PREVENT Pandemics Act” Retains FDA Reforms, Including “Platform” Pathway, Heading To Mark-Up

Accelerated Approval Legislative Crosswinds: GOP Bill Runs Directly Counter To Democratic Proposal; “Comprehensive Plan” Possible Area Of Compromise?

Prevision Policy Clips | Cancer Moonshot Gets About $200 Mil.; ARPA-H Funded At $1 Bil. As Separate Agency In HHS In Omnibus Spending Bill

Quality Metric Menu? FDA Suggests Moving Forward Quality Metric Reporting Initiative With Manufacturers Having Multiple Options For What To Report

Prevision Policy Clips | Quality Metric Reporting: FDA Solicits Comment On Plan To Proceed

Accelerated Approval Reforms Pushed By House Democrats Include Five-Year Expiration Date On License; Reforms To Withdrawal Process, Pre-Approval Conditions More Likely To Pass

CBER Emergency IND/Expanded Access Requests Return To Baseline After 2020 Spike; Still Show Clear Upward Trend Over Past Decade

“Misinformation” Research By HHS Builds On FDA Leadership Themes; HHS Highlights Unprecedented “Speed, Scale, And Sophistication” Of Spread

Prevision Policy Clips | Democratic Drug Pricing Policy Push Resumes With Senate Finance Hearing Planned

NASEM Supply Chain Report Recommends Public Disclosure Of FDA New Drug Volume Reports

Prevision Policy Clips | Health “Misinformation” On COVID-19 In The “Digital Information Environment” Is Topic Of Surgeon General Request For Information

Biden COVID Response Reset: Short-Term Surge In Antivirals, Long-Term Investments In Vaccine Production; FDA Review Praised

OCE Rides Cancer Moonshot Revival With Trio Of Final Guidances On Trial Design And Conduct; Changes From Drafts Are Minor

Prevision Policy Clips | PREVENT Pandemics Act Set For Mark-Up March 15: FDA Reforms

OCE Deputy Kluetz Highlights Opportunity For Prospective Use Of EHR Data For RWE Development At NASEM Workshop

Prevision Policy Clips | Pivot To Paxlovid? “Test To Treat” Initiative Unveiled By President Biden

Prevision Policy Clips | OCE Finalizes Three Oncology Guidances On Master Protocols, Expansion Cohorts, And Inclusion Of Older Adults

ALS Grants Are New Variation On Well-Established Theme Of Encouraging Expanded Access: Will It Change The Calculus For Drug Developers?

Prevision Policy Clips | 340B Program Office Has New Director: Emeka Egwim

Prevision Policy Clips | FTC Opens Docket On PBMs Following Deadlock Vote On Formal Investigation

Advisory Committee Tracker: Amylyx ALS Drug Review Highlights March Agenda; First CNS Meeting Since Aduhelm