FDA Highlights BE Data Falsification Enforcement At Generics Conference As Case Study For “Intersection” Between Inspection And Data Analysis

Prevision Policy Clips | White House To Nominate Duke Cardiologist Robert Califf As FDA Commissioner

Prevision Policy Clips | “Delinquent” Accelerated Approval Is Next Focus Of FDA Re-Review

ctDNA As Oncology Accelerated Approval Endpoint? FOCR Consortium Pushing Towards That Goal, But “Long Haul” Ahead

Prevision Policy Clips | Clinical Trial Diversity, Accelerated Approval Measures May Be PDUFA VII Add-Ons

Prevision Policy Clips | FDA Commissioner Candidate Califf Maintains Interest In Post-Approval Data Systems

Prevision Policy Clips | Part B Drug “Waste” Rebate Kicks In Jan. 1, 2023 After House Vote; Broader Drug Pricing Reforms Still TBD

FDA Cardiology/Endocrinology Office Being Led By Hylton Joffe On An Acting Basis, Janet Maynard Takes Reins Of Rare Disease

Prevision Policy Clips | Pfizer Oral Antiviral COVID-19 Treatment Shows 89% Reduced Risk Of Hospitalization Or Death

ALS “Action Plan” Would Be Required Of FDA Under Bill Moving Through House; Response To Patient Advocacy Stops Far Short Of “Conditional Approval”

Acting FDA Commissioner Woodcock Tries To Address McKinsey/Purdue Opioid Concerns At Senate HELP Hearing, But With Little Success

Levo Therapeutics Needs Another Trial For Prader-Willi Syndrome Treatment Carbetocin, FDA Advisory Committee Says; Confirms Negative FDA Review

Prevision Policy Clips | Tougher Than HR3: Democrats Drug Pricing Bill Has No Floor Price In Negotiation

Democratic Pricing Plan Leaves Launch Prices In Manufacturers’ Hands – But “Negotiation” May Be Tougher Than HR3

Prevision Policy Clips | Pfizer/BioNTech’s COVID Vaccine For 5-11 Year-Olds: CDC Presentations On Myocarditis, Unprecedented Surveillance Effort

ICER Panel Wants Bristol’s Mavacamten Price At About $15,000, Urges Patients To Press Sponsor Ahead Of Hypertrophic Cardiomyopathy Launch

Democratic Drug Price “Negotiation” Modifications Would Further Incentivize Biologic Product Development Versus Small Molecules

FDA Inspectional Backlog Flagged As Possible Impediment To BsUFA III Commitments During Feedback Meeting

Levo Therapeutics Carbetocin For PWS Appears Headed For FDA Rejection; Rare Disease Flexibility Still Has Limits, Agency Tells Advisory Committee

Prevision Policy Clips | FDA Acting Chief Scientist Jacqueline O’Shaughnessy Is Former FDA Inspector

Bespoke Gene Therapy Consortium Begins With 10 Corporate Partners; CBER’s Marks Is Key Advocate

Warning Letter Recovery Is New Focus For GDUFA III: FDA/Industry Deal Funds 128 New Staff, Adds “Complex” Generics To Product-Specific Guidance Program

Prevision Policy Clips | Acting Commissioner Woodcock Set To Testify At Senate COVID Hearing November 4

Rx Manufacturer CARES Act Quantity Reports Due Feb. 15 (For 2020), With 2021 Data Due In May; FDA Exempts Single-Use Gene/Cell Therapies, But Otherwise Scope Is Vast

Prevision Policy Clips | FDA Infrastructure Gets $300 Million In Build Back Better Bill