Prevision Policy Clips | Medicare Drug Price Negotiation Is Briefly Mentioned In Presidential Debate

Refuse-To-File “Easily Correctable” Problems Added To Revised CBER SOPP; Document Says Center Will “Attempt To Rectify” Those Issues

CDER Quantitative Medicine “Center Of Excellence” Plans Repository Of Case Studies; Mission Emphasizes Education About QM Successes

Prevision Policy Clips | BIOSECURE Clears House September 9; 79 Democrats Vote “No”

Prevision Policy Clips | BIOSECURE Act Set To Pass House During “China Week”

Prevision Policy Clips | FDA Preparing To Expand “Integrated Review” Template To More Applications, Wants Feedback

Gene Therapy Transition From AAV Vectors To CRISPR-Edited Products Over The Next Decade Should Lower Costs And Expand Access, CBER’s Marks Predicts

Iterum’s Sulopenem Appears Headed To Approval: FDA Wants Public Discussion Of Warning Against Off Label Use Beyond Uncomplicated UTI

FDA Eager To “INTERACT” With Start-Ups: Webinar Emphasizes Range Of Meeting Opportunities, Enthusiasm Of Agency To Engage

Prevision Policy Clips | Stealth Bio Elamipretide For Barth Syndrome Set For Cardio-Renal Advisory Committee Review October 10

Prevision Policy Clips | FDA Updates Nitrosamine Guidance To Set August 1 Deadline For NDSRI Testing

Prevision Policy Clips | FDA Vaccines Office Deputy Is Karin Bok

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