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Prevision Policy Clips | FDA “Investigating” CAR-T Linked Malignancies; Affirms Positive Benefit-Risk Ratio
November 29, 2023
Prevision Policy Clips | On-Shoring Rx Manufacturing: HHS Plans $35 Million Investment
November 28, 2023
Advisory Committee Tracker: A Quiet End To A Busy Year
November 27, 2023
Prevision Policy Clips | FDA Oncology Chief Richard Pazdur, CBER Head Peter Marks Headline The 2024 Biopharma Congress On February 26
November 27, 2023
Prevision Policy Clips | HELP Committee Democrats Ask J&J, Bristol And Merck CEOs To Appear January 24
November 22, 2023
Prevision Policy Clips | After Makena: Preterm Birth Drug Development Meeting Hosted By FDA/Duke-Margolis Scheduled For January 23-24
November 21, 2023
Merck’s Gefapixant Rejected By FDA Panel: Large Placebo Response, Small Benefit Sink Chronic Cough Application Despite Relatively Clean Safety Profile
November 20, 2023
DTC “Major Statement” Rule Finalized At Last: FDA Acknowledges Change In Technology Since 2010 Proposal – But Says Principles Of “Clear, Conspicuous And Neutral” Still Apply
November 20, 2023
Prevision Policy Clips | Bad KarMMa? Bristol/2seventybio Abecma Label Expansion Heads To Advisory Committee, Review Extended
November 20, 2023
Prevision Policy Clips | End Of An Era: FDA Commissioner Califf To Name Successor “In The Future” To Principal Deputy Janet Woodcock Following Her Retirement In Early 2024
November 17, 2023
Acrotech Confirmatory Study Plan For Lymphoma Drugs Not “Reasonable,” ODAC Says; Changes Likely After Pazdur Arm-Twisting In Latest Accelerated Approval Showcase
November 17, 2023
Prevision Policy Clips | “Thank You And Have A Great Day”: CMS Ends J&J Xarelto Patient-Listening Session Abruptly With No Agency Comments On What’s Next
November 16, 2023
Post-Market Evidence Generation: FDA Commissioner Califf Says “Common Lexicon” Is Coming; Priorities Include Reducing Data Redundancies
November 15, 2023
Merck Cough Therapy Gefapixant Review Hinges On Whether Cough Reduction Is Large Enough To Be Clinically Meaningful; PROs May Be Key Support – If Committee Agrees
November 15, 2023
FDA’s Pragmatic Approach To Pragmatic Cancer Trials: OS Is Only Viable Endpoint For Now, But Pared-Down Eligibility Criteria, Safety Data Can Be More Broadly Applied
November 15, 2023
Project Optimus Update: Discussion Has Shifted From “Why” To “How” To Do Dose Optimization, FDA Says; Friends Of Cancer Research White Paper Emphasizes Role For PROs
November 15, 2023
Prevision Policy Clips | FDA Shutdown Deadline Pushed To January 19 Under House Continuing Resolution
November 15, 2023
“Tough Love” On Accelerated Approvals: Acrotech's Folotyn, Beleodaq Delays Will Not Prompt Withdrawal – But FDA Is Declaring "Never Again" In ODAC Review
November 14, 2023
Prevision Policy Clips | Another PI3K-Inhibitor Goes Down: Bayer Pulls NDA Of Aliqopa After CHRONOS-4 Confirmatory Trial Fails To Meet Primary Endpoint
November 14, 2023
Prevision Policy Clips | Clinical Trial Diversity, Embracing “Learning-Based Analytical Tools,” Leveraging “Commonalities Across All Diseases” Are Key Priorities For NIH Director Bertagnolli
November 13, 2023
Prevision Policy Clips | Office Of Pharmaceutical Quality Reorganization To Take Effect January 14
November 10, 2023
Prevision Policy Clips | Jardiance CMS Patient-Listening Session Features Talk Of Benefits, More Concerns About Access After Negotiations
November 9, 2023
Rebate Pass-Through Bill Heads To Senate Floor: Amendment Directs GAO To Study Impacts Of New Policy; CBO Still Sees Costs Going Up; Biosimilar Tiering Provision Needs More Work
November 8, 2023
Prevision Policy Clips | NIH Director Bertagnolli: Senate Confirms Nominee 62-36 Despite Two “No” Votes From Democrats
November 8, 2023
Rare Disease Review Flexibility Will Be Focus Of National Academies Report; Kick-Off Meeting Highlights Disconnect Between FDA’s Perceptions And Those Of Patients
November 7, 2023
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