Prevision Policy Clips | Cell & Gene Therapies Safety Project, Rare Neurodegenerative Diseases Task Force Part Of FDA ALS Action Plan

Rescinding “Breakthrough Therapy”: Accelerated Approval Of Another Drug Not Enough To Take Away BTD, FDA Guidance Says

Prevision Policy Clips | Breakthrough Therapy Guidance Lists Three Considerations For Rescinding Designation Including A Different Drug Approved

FTC/DOJ Antitrust Workshop Puts Large-With-Large Biopharma Mergers In Crosshairs; PBM Contracts, Formulary Position Should Be Watched Closely

Prevision Policy Clips | “Rebate Rule” Delay Is Funding Source For Bipartisan Gun Legislation

Prevision Policy Clips | Makena AA Withdrawal Hearing Questions Include Final Vote On Whether Drug Should Remain Available While “Appropriate”

Acadia’s Nuplazid For Alzheimer’s Psychosis Fails On De Facto Appeal; FDA Psychopharm Panel Agrees With FDA That Another Trial Needed In ADP

Prevision Policy Clips | FTC Unanimously Votes To Increase Scrutiny Of Insulin Rebate Practices

CBER Pursuing Operation Warp Speed For Rare Diseases, But Staffing Challenges Preclude Progress; OTAT Director Bryan Is “Reconsidering” Review Office Structure

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