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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
FDA “Diversity Plan” Analysis Shows Steep Learning Curve For Oncology Sponsors; Only Small Fraction Of OCE Submissions Were “Acceptable” In First Year
November 30, 2023
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