Prevision Policy Clips | FDA Encourages A-syn Biomarker For Patient Selection in Parkinson’s

FDA Vaccine Office After COVID: Low-Profile, Experienced Leaders Underlie High-Profile Approvals

CDER Artificial Intelligence Council Will Catalogue & Coordinate AI Activities In The Center; Another Structural Move To Address Emerging Field

Prevision Policy Clips | House Oversight Chair James Comer (R-Ky.) Requests Hearing Testimony Correction From PBM Chief Executives

Prevision Policy Clips | Senate HELP Committee Chair Bernie Sanders Highlights Lilly Announcement To Lower Zepbound Starter Dose List Price

Advisory Committee Tracker: They’re Back! In-Person Meetings Resume And FDA Has Plenty On Tap; ODAC Will Look At Another PD-1 Labeling Issue

Prevision Policy Clips | Patient-Friendly Informed Consent Will Be Focus Of FDA Patient Engagement Advisory Committee Meeting October 30

Prevision Policy Clips | 340B Rebate? J&J Tells DSH Hospitals That Stelara And Xarelto 340B Prices

Schizophrenia Drug Development: FDA Urges Importance Of Studying “Negative Symptoms” In Clinical Trials, Farchione Rethinks Early Advice On Phase III Design

Prevision Policy Clips | FDA Rare Neurodegenerative Disease Grant Program Looking For Innovative Trial Designs

BLA Facility-Related Rejections Increasing Within CDER: FDA Urges Increased Communication; China Backlog Cleared But Challenges Remain

Prevision Policy Clips | ODAC PD-L1 Reviews Set For September 26 In Gastric, Esophageal Cancers

Prevision Policy Clips | Happy Halloween: Sotagliflozin Heads To FDA Advisory Committee October 31 In Next Stop Of Tortured Regulatory History

Prevision Policy Clips | Project Orbis Approval: Johnson & Johnson’s sBLA For Lazcluze (Lazertinib) Gets FDA Approval

Generic Drug Sponsors May Discuss Alternative Approaches To BE Requirements During Pre-ANDA Meetings In Finalized Guidance; Teva Requested Change

CMS Declares Importance Of Observational/RWE Studies To CED; Upcoming “Fit-For-Purpose” Guidance Will Define Acceptable Studies

Prevision Policy Clips | Harris Administration Would “Accelerate The Speed Of Medicare Negotiations” For Rx Drugs

Prevision Policy Clips | VP Kamala Harris Applauds “Bold" CMS Administrator Brooks-LaSure; Highlights Role In Passing IRA

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

Prevision Policy Clips | Medicare Drug Price Cuts All Over 50% Except For One (Imbruvica) In The Inaugural Class of 10 Part D Drugs

FDA Advisory Committee Benefit/Risk Votes Should Be Taken On Verbatim Indication, Survey Finds; Members With Conflicts Should Be Non-Voting

Prevision Policy Clips | FDA Science Board To Meet October 7 To Discuss Agency Reorganizations, Reducing Animal Testing

Prevision Policy Clips | "I Worked Very Hard On That," Former President Donald Trump Says Of FDA Drug Review Times

Randomized Trials Are “Preferrable” In Non-Muscle Invasive Bladder Cancer, Updated FDA Guidance Says; BCG Shortage Addressed In Revision

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"