Prevision Policy Clips | FDA India Office Director Greg Smith Will Oversee Key International Outpost

Zevra’s Arimoclomol Will Be Tough First Review For GeMDAC; FDA Still Has Reservations About Efficacy In Niemann-Pick – But Leaves Room For A “Yes”

Prevision Policy Clips | Merck Responds To FDA Concerns About “Peri-Operative” Trial Designs

User Fee Rates For FY 2025: PDUFA Fees Stay Relatively Stable; Big Increases In Filing Fees For ANDAs And Biosimilars

Prevision Policy Clips | Part D Premium Fluctuations Prompt CMS To Offer Additional Stabilization Measures For 2025

Advisory Committee Tracker: GeMDAC Inaugural Meeting Will Test Waters For Rare Disease Reviews In CDER; Adcomms Themselves Remain Very Rare At FDA

Prevision Policy Clips | Vertex Non-Opioid Suzetrigine For Acute Pain Will Be Reviewed By ICER At February 2025

AI For Real World Data Generation: FDA Highlights Risk-Based Approach To Adoption For Regulatory Applications

House PBM Reform Hearing Points To Renewed Legislative Push In 2025: “Busting Up” The Big Three Could Be A Theme

Prevision Policy Clips | HHS Acting Chief AI Officer Will Be Micky Tripathi

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FDA Biosimilar Post-Approval Changes Draft Guidance Includes Path For Dose/Formulation Supplements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