Gene Editing Draft Guidance: FDA Recommends Staggered Enrollment With Children Last; “Clinically Meaningful” Primary Endpoint A Requirement

PREVENT Bill Mark-Up: FDA “Gold Standard” Extolled As Key Lesson Coming Out Of COVID; US Manufacturing Base Remains In Spotlight, LDT Reform Deferred

Prevision Policy Clips | FDA Gene Editing, CAR-T Draft Guidances Published March 15

Amyloidosis Public-Private Partnership With FDA Working on Multi-Domain Endpoints, Federated Data Analytics Approach

FDA Defends Accelerated Approval Follow-Up Process With Data; Is Low Withdrawal Rate A Sign Of A Different Problem?

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