Prevision Policy Clips | Price Negotiation Year 2: Manufacturers Will Have Mid-December Deadline To Request Exemptions

Prevision Policy Clips | Schizophrenia Drug Development: FDA Meeting On Approaches To “Negative Symptoms”

Prevision Policy Clips | “Reshoring” Drug Production: DoD Pressed To Do More

FDA Advisory Committee “Listening Session”: Stakeholder Outreach Unlikely To Prompt Major Changes; Fighting Misperceptions Is One Theme

Advisory Committee Tracker: Novo Once-Weekly Insulin Will Head To Committee In May; Donanemab, Ocaliva Reviews In The Works

FDA Quantitative Medicine Center Aims To Move Drug Development Move Away From “Ad Hoc” Use Of Modeling And Simulation; OCP’s Madabushi Is First Director

FDA OCE Questions “Unnecessarily Restrictive Eligibility Criteria” With Three New Guidances On Lab Values, Washout Periods, And Performance Status

Prevision Policy Clips | Public “Persistent Misconception” Of FDA Advisory Committees One Topic For Discussion

LDT Final Rule Takes Lighter Touch: Existing Tests Will Be “Grandfathered” But Subject To More FDA Scrutiny; New Versions Will Be Subject To Pre-Market Review

What If Trump Wins? Risk Of FDA Departures, But Maybe “Shaking The Tree Wouldn’t Be A Bad Thing”: CMS Models Would Continue; Jindal For HHS?

Prevision Policy Clips | Cell/Gene Therapy CMCs: CBER Guidance Addresses Unique Issues

Prevision Policy Clips | Novo Nordisk Once-Weekly Insulin Icodec Subject Of FDA Advisory Committee May 24

Prevision Policy Clips | FDA Cancer Trial Eligibility Guidances Seek Broader Inclusion Criteria In Three Areas

CBER Gene Therapy Office Likely To Need More Staff In Coming Years; Strategic Planning Will Be Critical For Evolution Of Hybrid Work, Director Marks Says

Prevision Policy Clips | CBER “Focus On The Patient” Initiative Coming Soon, Director Peter Marks Says

CBER Gene Therapy Accelerated Approval Guidance Will Describe Three Scenarios Based On Biomarkers, Marks Says; CRISPR “Platform” Guidance Also Planned

Prevision Policy Clips | LDT Final Rule Coming Soon? FDA Lab Developed Test Regulation Cleared By OMB “Consistent With Change”

Prevision Policy Clips | FDA Annual Postmarket Requirements/Commitments Report For FY 2022 Likely To Focus On Number Of Overdue PMRs

Generic Drug Supply Chain Complexity Could Complicate Proposed Shortage Solutions, MedPAC Commissioner Suggests; New Pricing Data Underscore “Variability”

340B Pricing Averages ASP-29% For Part B Hospitals, MedPAC Data Show; Commission Disclaims Immediate Policy Agenda

Prevision Policy Clips | Gene Therapy BLA CMC Readiness Is Subject OTP Town Hall

HHS Inter-Agency Real-World Data Registry Collaboration Underway; NIH Looking Separately To Collaborate With FDA In The Post-Market

FDA Foreign Inspections “On The Way Back” But “Not There Yet,” Califf Tells House Appropriators; Return To Cordial Tone In FDA Oversight On Hill

Prevision Policy Clips | House Republicans Criticize FDA Lab-Developed Test Regulation Proposal At HHS Budget Hearing

Prevision Policy Clips | OCE “Project Asha” Collaboration With India Will Focus On Clinical Trials And Research Training