Advisory Committee Tracker: The Lull Continues Into 2024

Prevision Policy Clips | Happy New Year? 17 Days Until Next FDA Shutdown Deadline

Prevision Policy Clips | Rare Disease Drug Development Guidance Finalized By FDA: Revisions Include Discussion Of Patient Input

Real-World Evidence Policy Taking Shape: FDA Finalizes Two More RWE/RWD Documents Along With Digital Health Tools Guidance As 2023 Draws To A Close

Prevision Policy Clips | Randomized Umbrella And Platform Trials Are Main Focus Of FDA Master Protocols Draft Guidance

Merck Sotatercept PAH Treatment Being Watched For Price Impact On Other Orphans; Dec. 1 ICER Meeting Confirms Clinical Benefits, Launch Price Concerns

Prevision Policy Clips | FDA Reissues COVID MAb Development Guidance To Support Ongoing EUAs

Adult ADHD Drug Development: FDA Awaiting Clinical Guidelines As Key Milestone; Seeks Balance To Ensure Appropriate Diagnosis Amid Shortages, Abuse Potential

Prevision Policy Clips | FDA/Industry Face-To-Face Meetings Will Expand To “All Meeting Types” Under PDUFA, BsUFA, and OMUFA Starting January 22

Prevision Policy Clips | Part B Inflation Rebates: 59 Different Drugs Owe Rebates In First Year

Cell/Gene Therapy Products Take Center Stage In Kick-Off Of CMS “New Technology” Payment Cycle; New Rules On FDA Status Reduce Number Of Candidates For FY25 NTAP “Town Hall”

Medicare Inflation Rebates: CMS Will Give 30 Days To “Suggest Errors” In First Rounds Of Invoices; Revised Guidance Provides Only Limited Relief For Most Drugs In Shortage

Prevision Policy Clips | FDA Formalizes Withdrawal Of AbbVie/J&J Imbruvica MCL/MZL Indications; ODAC Threat

FDA Advanced Manufacturing Technology Designation Guidance Uses Broad Criteria For “Novel” Technology; Will CBER’s CATT Help AMT Program Purr?

Prevision Policy Clips | CMS Updates IRA Medicare Inflation Rebate Guidances To Clarify Relief For Drugs In Shortage

Drug-Drug Interactions: Future FDA Guidance Will Focus On Specific Modalities; Patient-Targeted DDI Website Under Development

Valneva Ixchiq Chikungunya Vaccine Showcases FDA Use Of Accelerated Approval And Non-COVID Vaccine Work During Pandemic; “Pragmatic” Confirmatory Trial Is Key Factor In Decision

FDA “Office of Inspections & Investigations” Re-Org Plan Finalized Pending HHS/OMB Clearance; Restructuring Would Expand Role Of CMO, Create New Office Of Enterprise Transformation

Prevision Policy Clips | FDA Opioid Approval Standard Would Be Raised, Non-Opioid Chronic Pain Guidance Demanded

Prevision Policy Clips | FDA Genetic Metabolic Diseases Advisory Committee Will Be New Panel

Sickle Cell Tandem Approvals For Vertex’ Casgevy, Bluebird’s Lyfgenia: Timing Downplays Differences, But Regulatory And Commercial Distinctions Have Broad Implications For Gene Editing/Gene Therapy

Prevision Policy Clips | Sickle Cell Tandem Approvals: Bluebird Bio, Vertex/CRISPR Treatments Cleared Simultaneously, But Price And Labeling Differences Stand Out

National Hepatitis C “Subscription” Treatment Plan Could Launch In 2024, White House Advisor Collins Says: Timeline Hinges on CBO Score; Collins Confident Gilead And AbbVie Will Participate

House Energy & Commerce Pushes Through PBM Payment Reforms, Biosimilar Access Legislation Ahead Of New Year

Prevision Policy Clips | Sen. Sanders’ Luke-Warm Response To White House “March In” Framework: “Step Forward”