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AI For Real World Data Generation: FDA Highlights Risk-Based Approach To Adoption For Regulatory Applications
July 26, 2024
House PBM Reform Hearing Points To Renewed Legislative Push In 2025: “Busting Up” The Big Three Could Be A Theme
July 26, 2024
Prevision Policy Clips | HHS Acting Chief AI Officer Will Be Micky Tripathi
July 26, 2024
AZ Imfinzi On Track For Broad Label In Early-Stage Lung Cancer—But Door Is Closing For “Peri-Operative” Claims Without Bigger Trials
July 25, 2024
Prevision Policy Clips | ARPA-H Real World Data Request For Information
July 25, 2024
CDRH Director Transition Will Have Tarver Overseeing Early Implementation Of LDT Rule; Will Other Center Directors Leave In 2025?
July 24, 2024
“Type D” Meetings Are Taking Off At FDA, Though Scope Of Questions Can Be An Issue; “Virtual” Meetings Are Generally Popular With Sponsors
July 24, 2024
Prevision Policy Clips | FDA Appropriations: White House Says It Would Veto House Version
July 24, 2024
AstraZeneca’s Imfinzi For NSCLC: ODAC Likely To Recommend Approval After Wading Through AEGEAN, But Future Perioperative Applications Will Require New Trial Designs
July 23, 2024
Prevision Policy Clips | House Oversight Committee Releases PBM Report Ahead Of July 23 Hearing
July 23, 2024
FDA Biosimilar Post-Approval Changes Draft Guidance Includes Path For Dose/Formulation Supplements
July 22, 2024
VP Kamala Harris Marches In To Presidential Campaign, Could “March-In” On Drug Prices If Elected
July 22, 2024
Prevision Policy Clips | Democratic Campaign Shakeup Means New President Will Appoint Next FDA Commissioner
July 22, 2024
OCE’s Lucky Seven (Years): Oncology Reviewers Reflect On Center’s Success, Name Assessment Aid And “Project Facilitate” As Favorite Programs
July 19, 2024
Prevision Policy Clips | Ardelyx Sues CMS To Block Xphozah Payment Change
July 19, 2024
Working Toward An FDA Rare Disease Center: “Hub” Locks In Compromise Approach For Now
July 18, 2024
Prevision Policy Clips | FDA Formally Unveils “Rare Disease Innovation Hub”; CDER Seeks New Associate Director For Rare Disease Strategy
July 18, 2024
FDA Approval Decisions May Face Legal Challenges Post-Chevron – But Not In The Near Term, Legal Analysts Suggest
July 17, 2024
GeMDAC Starts Small: Four Members Named To FDA’s Newest Advisory Committee Ahead Of Inaugural Meeting; Six Vacancies Remain
July 17, 2024
Prevision Policy Clips | Genetic Metabolic Diseases Advisory Committee: FDA Announces First Four Members
July 17, 2024
FDA Appropriations Bills Point Towards Flat Funding; House And Senate Committees Show Interest In Accelerated Approval, DEA Scheduling, Psychedelics, And Drug Shortages
July 16, 2024
Prevision Policy Clips | FDA Extends Platform Technology Designation Guidance Comment Period To Aug. 28
July 16, 2024
Prevision Policy Clips | Partial-Onset Seizure Therapeutics: FDA Revises Guidance To Include Efficacy Extrapolation From Adults To Infants
July 15, 2024
Prevision Policy Clips | BIOSECURE Act Path To Enactment Taking Shape: Senate May Attach House Version To Defense
July 12, 2024
Medicare Inflation Rebate Reconciliation Process Added In Regulatory Codification; CMS Proposes To “Estimate” 340B Units For Part D Rebate Exclusion
July 11, 2024
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