OCE Project Confirm Takes Shape: Ongoing Confirmatory Trials At Time Of AA Offers Average Two-Year Faster Approval Conversion

FDA’s Vaccines Advisory Committee Unanimously Recommends Authorization Of Pfizer, Moderna COVID Vaccines In Young Children; Agency Will Turn Attention To Strain Composition For 2022/2023

Prevision Policy Clips | 340B Part B Payment Cuts “Unlawful,” Supreme Court Rules

RCT-DUPLICATE Project Will Guide Future RWE Guidances; Four-Year Project In Claims Data Identifies Issues To Watch

FDA Inspections Update: Domestic Pre-Approval Inspection Backlog Has Been Cleared; China Remains “Difficult” For Resuming Normal Work

FDASLA Moves Forward In Senate, But GOP Sponsor Becomes “Burr” To Smooth Progress; User Fee Bill Moves Closer To House Version, But Tone Diverges Sharply

Acadia’s Nuplazid For Alzheimer’s Psychosis: FDA Panel Review Will Serve As Long-Shot Appeal; Agency “Does Not Agee” With Arguments For New Use

Prevision Policy Clips | Regenerative Medicine “Consensus Standards” Program Modeled On Devices Proposed By CBER

Accelerated Approval Reforms: FDA’s Califf Sees Evidence Generation—Not Speed To Market—As Correct Focus For Legislation

Senate User Fee Bill Would Codify FDA Certification Program For Canadian Rx Imports: Stronger Legal Basis But Also Likely Further Delay In Implementation

Prevision Policy Clips | Senate FDA User Fee Bill Adds Provision Codifying Canadian Import Certification Process

CBER Advanced Technologies Team Getting “High Interest” From Industry On Platform Technologies; Center Coordinating With CDER On Advanced Manufacturing Evaluation Framework

Prevision Policy Clips | FDA Commissioner Califf Set To Testify At Senate HELP COVID Response Hearing June 16

Bluebird Beti-Cel Takes FDA Back To Gene Therapy Replacements For Current Treatments; Thalassemia Vote Means Bluebird Has Two BLAs To Finish Over Summer

Quantifying The Slowdown In Gene/Cell Therapy INDs During COVID: Gene Therapy Submissions Plateau In 2021, Dropoff Seen In Cell Therapy Submissions

Prevision Policy Clips | Gene Therapy Regulatory Environment Gets Nice Boost From Bluebird Bio Unanimous Eli-Cel Vote

Bluebird Bio’s Eli-Cel: FDA Asks Sponsor For Analysis On Unmatched Donor Sub-Group; That Impresses Advisory Committee, Earns Unanimous OK

FTC Study Of PBMs Digs Deep On Specific Drug Classes: Broad Scope But Impact Depends On Political Climate When Report Is Done; Prior Authorization Policy May Be Sleeper Issue

Prevision Policy Clips | “FDA22” User Fee Reauthorization Passes House

Novavax COVID-19 Vaccine Breezes Through Committee Thanks To FDA Case For Unmet Need; Manufacturing Review Is Final Obstacle To EUA

Prevision Policy Clips | FTC Launches Broad Study Of PBM Practices, Asking Top Six PBMS About Seven Different Topics

Bluebird’s Beti-Cel Thalassemia Gene Therapy: FDA Asking Committee How To View “Worrisome” Long-Term Safety Concerns In Face Of Clinical Benefit

Bluebird’s Eli-Cel For CALD: Complex Review Includes Cancer Risk Among Safety Concerns Mixed With Efficacy Interpretability Challenges Posed By FDA

CDER Workplace “Culture” Is Focus Of Retention Efforts After COVID; Re-Vamped “Equal Voice” Process Is One Step

Prevision Policy Clips | House Expected To Pass FDA User Fee Reauthorization Bill Today