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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
December 15, 2023
Prevision Policy Clips | FDA Formalizes Withdrawal Of AbbVie/J&J Imbruvica MCL/MZL Indications; ODAC Threat
December 15, 2023
FDA Advanced Manufacturing Technology Designation Guidance Uses Broad Criteria For “Novel” Technology; Will CBER’s CATT Help AMT Program Purr?
December 14, 2023
Prevision Policy Clips | CMS Updates IRA Medicare Inflation Rebate Guidances To Clarify Relief For Drugs In Shortage
December 14, 2023
Drug-Drug Interactions: Future FDA Guidance Will Focus On Specific Modalities; Patient-Targeted DDI Website Under Development
December 14, 2023
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
December 13, 2023
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
December 13, 2023
Prevision Policy Clips | FDA Opioid Approval Standard Would Be Raised, Non-Opioid Chronic Pain Guidance Demanded
December 13, 2023
Prevision Policy Clips | FDA Genetic Metabolic Diseases Advisory Committee Will Be New Panel
December 12, 2023
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
December 11, 2023
Prevision Policy Clips | Sickle Cell Tandem Approvals: Bluebird Bio, Vertex/CRISPR Treatments Cleared Simultaneously, But Price And Labeling Differences Stand Out
December 11, 2023
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
December 8, 2023
House Energy & Commerce Pushes Through PBM Payment Reforms, Biosimilar Access Legislation Ahead Of New Year
December 8, 2023
Prevision Policy Clips | Sen. Sanders’ Luke-Warm Response To White House “March In” Framework: “Step Forward”
December 8, 2023
“Reasonable Price” Clause Would Return In Biden “March In” Framework: Unwelcome Headline For Innovators, But Draft Sets High Bar For Intervention – And Likely Small Impact If Implemented
December 7, 2023
Prevision Policy Clips | “Reasonable Pricing” Clause Reborn? Proposed “March In” Framework Unveiled By The Commerce Department
December 7, 2023
Pazdur As Book Critic: Big Sponsor/Small Sponsor Differences Are Clear To FDA Oncology Team, Director Declares In Discussion With Biotech Author
December 6, 2023
Prevision Policy Clips | FDA/Novartis Back-And-Forth On Kymriah Inspection Observations
December 6, 2023
Senate Finance Committee Zeroing In On Shortage Solutions: Hearing Highlights “Pay For Performance” And Targeted Manufacturing Investments As Potential Bipartisan Ideas
December 5, 2023
FDA “Digital Transformation” Entering More Visible And “Strategic” Stage, CIO Desai Says; Califf Warns That Siloed Approach In Government Remains A Threat To Overall Vision
December 5, 2023
Prevision Policy Clips | BIO Head Will Be Amicus CEO John Crowley
December 5, 2023
OTP Reorganization Has Increased Review Expertise In Specialty Disciplines, CBER Director Marks Says; “Live” Meeting Interactions Increasing Under Director Verdun
December 4, 2023
Prevision Policy Clips | FDA Vaccine Review Division Will Be Split In Two
December 4, 2023
Diversity In Clinical Trials: Early Planning To Include Underrepresented Populations Will Prevent Slowdowns In Drug Development, FDA’s Stein Says
December 1, 2023
Prevision Policy Clips | Clinical Trial Remuneration Could Increase Diversity Among Study Populations, FDA Office Of Medical Policy Deputy Director Karen Hicks
December 1, 2023
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