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BLA Facility-Related Rejections Increasing Within CDER: FDA Urges Increased Communication; China Backlog Cleared But Challenges Remain
August 22, 2024
Prevision Policy Clips | ODAC PD-L1 Reviews Set For September 26 In Gastric, Esophageal Cancers
August 22, 2024
Prevision Policy Clips | Happy Halloween: Sotagliflozin Heads To FDA Advisory Committee October 31 In Next Stop Of Tortured Regulatory History
August 21, 2024
Prevision Policy Clips | Project Orbis Approval: Johnson & Johnson’s sBLA For Lazcluze (Lazertinib) Gets FDA Approval
August 20, 2024
Generic Drug Sponsors May Discuss Alternative Approaches To BE Requirements During Pre-ANDA Meetings In Finalized Guidance; Teva Requested Change
August 19, 2024
CMS Declares Importance Of Observational/RWE Studies To CED; Upcoming “Fit-For-Purpose” Guidance Will Define Acceptable Studies
August 19, 2024
Prevision Policy Clips | Harris Administration Would “Accelerate The Speed Of Medicare Negotiations” For Rx Drugs
August 19, 2024
Prevision Policy Clips | VP Kamala Harris Applauds “Bold" CMS Administrator Brooks-LaSure; Highlights Role In Passing IRA
August 16, 2024
CMS Sets The Negotiation Bar: 60% Off List Price Appears To Be The Baseline Going Forward; Diabetes Makes Up Four Of Top Five, Cancer Drugs May Feel Greatest Impact
August 15, 2024
Prevision Policy Clips | Medicare Drug Price Cuts All Over 50% Except For One (Imbruvica) In The Inaugural Class of 10 Part D Drugs
August 15, 2024
FDA Advisory Committee Benefit/Risk Votes Should Be Taken On Verbatim Indication, Survey Finds; Members With Conflicts Should Be Non-Voting
August 14, 2024
Prevision Policy Clips | FDA Science Board To Meet October 7 To Discuss Agency Reorganizations, Reducing Animal Testing
August 14, 2024
Prevision Policy Clips | "I Worked Very Hard On That," Former President Donald Trump Says Of FDA Drug Review Times
August 13, 2024
Randomized Trials Are “Preferrable” In Non-Muscle Invasive Bladder Cancer, Updated FDA Guidance Says; BCG Shortage Addressed In Revision
August 12, 2024
Prevision Policy Clips | Lykos To Request An FDA Meeting For A "Reconsideration Of The Decision" To Reject The MDMA Therapy, Will Pursue "All Available Regulatory Pathways"
August 12, 2024
Rare Disease Innovation Hub October Kick-Off Meeting Will Solicit Input On “Specific” Policy Priorities, Engagement Practices; OCE To Be Involved
August 9, 2024
Prevision Policy Clips | FDA Rare Disease "Hub" Priorities Are The Focus Of Oct. 16 In-Person Workshop
August 9, 2024
FDA Digital Health Advisory Committee To Be Led By ACC’s Bhatt: Generative AI Use In Devices Will Be Focus Of Inaugural Meeting In November
August 8, 2024
Prevision Policy Clips | CMS Declines To Set Expiration Date On Coverage With Evidence Development
August 8, 2024
FDA AI Policy: “Clarity Will Foster Innovation,” CDER’s Cavazzoni Says; “Context Of Use” Will Be Key Consideration For Risk-Based Approach In Upcoming Guidance
August 7, 2024
Prevision Policy Clips | FDA Draft Guidance On Use Of AI In Drug/Biological Development “Coming Soon,”
August 7, 2024
Harris VP Pick Walz Pushed Drug Pricing Transparency Policies; Capping Insulin Co-Pays, PDAB Also On Minnesota Governor’s Progressive Agenda
August 6, 2024
Prevision Policy Clips | Lykos’ MDMA NDA: FDA Decision Watched By Bipartisan Group Of Senators
August 6, 2024
Zevra’s Arimoclomol Clears FDA Advisory Committee In Niemann-Pick; GeMDAC Endorses Small But Consistent Efficacy In Inaugural Meeting
August 5, 2024
Prevision Policy Clips | Adaptimmune Tecelra Accelerated Approval: Short Confirmatory Trial Plan
August 5, 2024
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