AZ Imfinzi On Track For Broad Label In Early-Stage Lung Cancer—But Door Is Closing For “Peri-Operative” Claims Without Bigger Trials

Prevision Policy Clips | ARPA-H Real World Data Request For Information

CDRH Director Transition Will Have Tarver Overseeing Early Implementation Of LDT Rule; Will Other Center Directors Leave In 2025?

“Type D” Meetings Are Taking Off At FDA, Though Scope Of Questions Can Be An Issue; “Virtual” Meetings Are Generally Popular With Sponsors

Prevision Policy Clips | FDA Appropriations: White House Says It Would Veto House Version

AstraZeneca’s Imfinzi For NSCLC: ODAC Likely To Recommend Approval After Wading Through AEGEAN, But Future Perioperative Applications Will Require New Trial Designs

Prevision Policy Clips | House Oversight Committee Releases PBM Report Ahead Of July 23 Hearing

FDA Biosimilar Post-Approval Changes Draft Guidance Includes Path For Dose/Formulation Supplements

VP Kamala Harris Marches In To Presidential Campaign, Could “March-In” On Drug Prices If Elected

Prevision Policy Clips | Democratic Campaign Shakeup Means New President Will Appoint Next FDA Commissioner

OCE’s Lucky Seven (Years): Oncology Reviewers Reflect On Center’s Success, Name Assessment Aid And “Project Facilitate” As Favorite Programs

Prevision Policy Clips | Ardelyx Sues CMS To Block Xphozah Payment Change

Working Toward An FDA Rare Disease Center: “Hub” Locks In Compromise Approach For Now

Prevision Policy Clips | FDA Formally Unveils “Rare Disease Innovation Hub”; CDER Seeks New Associate Director For Rare Disease Strategy

FDA Approval Decisions May Face Legal Challenges Post-Chevron – But Not In The Near Term, Legal Analysts Suggest

GeMDAC Starts Small: Four Members Named To FDA’s Newest Advisory Committee Ahead Of Inaugural Meeting; Six Vacancies Remain

Prevision Policy Clips | Genetic Metabolic Diseases Advisory Committee: FDA Announces First Four Members

FDA Appropriations Bills Point Towards Flat Funding; House And Senate Committees Show Interest In Accelerated Approval, DEA Scheduling, Psychedelics, And Drug Shortages

Prevision Policy Clips | FDA Extends Platform Technology Designation Guidance Comment Period To Aug. 28

Prevision Policy Clips | Partial-Onset Seizure Therapeutics: FDA Revises Guidance To Include Efficacy Extrapolation From Adults To Infants

Prevision Policy Clips | BIOSECURE Act Path To Enactment Taking Shape: Senate May Attach House Version To Defense

Medicare Inflation Rebate Reconciliation Process Added In Regulatory Codification; CMS Proposes To “Estimate” 340B Units For Part D Rebate Exclusion

Prevision Policy Clips | Senate FDA Appropriations Bill Gives FDA $22 Million Increase

Prevision Policy Clips | “Big Three” PBMs Reportedly To Testify At House Oversight Committee Hearing July 23

Drug/Device Combos: FDA Use-Related Risk Analysis Guidance Fleshes Out Agency’s Thinking On Best Approaches To URRAs As Guide For Human Factor Studies