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

FDA After COVID: CDER’s Key Learnings Remain De-Centralized Trials, Remote Inspections, And Supply Chain Oversight; EUA Transition Appears Manageable On New Drug Side

Prevision Policy Clips | FDA Labeling Webpages For Industry Include Patient Labeling Resources For Prescription Drugs

Novavax COVID Vaccine Appears To Meet EUA Standards Set By FDA In 2020; Will Advisory Committee Support Applying That Model In 2022?

Prevision Policy Clips | Amylyx ALS Drug AMX0035 Receives Three-Month User Fee Deadline Extension To September 29

Prevision Policy Clips | FDA User Fee Reauthorization Bill Set For Senate Mark-Up June 8

Advisory Committee Tracker: A Busy June For CBER Committees; Y-mAbs, Reata Expect Reviews For Their Newly Filed Applications Later This Year

Prevision Policy Clips | FTC/DoJ Workshop On Pharmaceutical Industry Mergers And Antitrust Enforcement Set For June 14-15

Prevision Policy Clips | Drug Pricing Bubbling Back Up As Manchin, Schumer Talks Get More Serious

Senate User Fee Bill Directs FDA To Set Up Internal “Accelerated Approval Council”; Other AA Provisions Largely Harmonize With House Approach

CDER/CBER Are Aligned On ARC Rare Disease Initiative; Surrogate Endpoint/Biomarker Work Should Start Early, Agency Officials Say At FDA/Duke Margolis Workshop

Prevision Policy Clips | Novavax COVID Vaccine EUA Request Set For June 7 Advisory Committee Review

FDA Quality Management Maturity Initiative Aims To Be “Proactive And Rewarding” For Sponsors; “Encourage More, Punish Less” Is OPQ Theme

Prevision Policy Clips | ARPA-H Staffing Begins With Ex-DARPA Program Manager Adam Russell

FDA/Industry Quality Management Maturity Pilot Sets Outline For Viable Program; Details To Be Filled In – Including FDA Role In QMM Assessments

Rx Import Q&A Guidance Reiterates Plan Parameters Outlined In Final Rule; FDA Showing Step Forward Without Opening Border?