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OCE Project Confirm Takes Shape: Ongoing Confirmatory Trials At Time Of AA Offers Average Two-Year Faster Approval Conversion
June 16, 2022
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
June 16, 2022
Prevision Policy Clips | 340B Part B Payment Cuts “Unlawful,” Supreme Court Rules
June 16, 2022
RCT-DUPLICATE Project Will Guide Future RWE Guidances; Four-Year Project In Claims Data Identifies Issues To Watch
June 15, 2022
FDA Inspections Update: Domestic Pre-Approval Inspection Backlog Has Been Cleared; China Remains “Difficult” For Resuming Normal Work
June 15, 2022
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
June 15, 2022
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
June 15, 2022
Prevision Policy Clips | Regenerative Medicine “Consensus Standards” Program Modeled On Devices Proposed By CBER
June 15, 2022
Accelerated Approval Reforms: FDA’s Califf Sees Evidence Generation—Not Speed To Market—As Correct Focus For Legislation
June 14, 2022
Senate User Fee Bill Would Codify FDA Certification Program For Canadian Rx Imports: Stronger Legal Basis But Also Likely Further Delay In Implementation
June 14, 2022
Prevision Policy Clips | Senate FDA User Fee Bill Adds Provision Codifying Canadian Import Certification Process
June 14, 2022
CBER Advanced Technologies Team Getting “High Interest” From Industry On Platform Technologies; Center Coordinating With CDER On Advanced Manufacturing Evaluation Framework
June 13, 2022
Prevision Policy Clips | FDA Commissioner Califf Set To Testify At Senate HELP COVID Response Hearing June 16
June 13, 2022
Bluebird Beti-Cel Takes FDA Back To Gene Therapy Replacements For Current Treatments; Thalassemia Vote Means Bluebird Has Two BLAs To Finish Over Summer
June 13, 2022
Quantifying The Slowdown In Gene/Cell Therapy INDs During COVID: Gene Therapy Submissions Plateau In 2021, Dropoff Seen In Cell Therapy Submissions
June 10, 2022
Prevision Policy Clips | Gene Therapy Regulatory Environment Gets Nice Boost From Bluebird Bio Unanimous Eli-Cel Vote
June 10, 2022
Bluebird Bio’s Eli-Cel: FDA Asks Sponsor For Analysis On Unmatched Donor Sub-Group; That Impresses Advisory Committee, Earns Unanimous OK
June 10, 2022
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
June 9, 2022
Prevision Policy Clips | “FDA22” User Fee Reauthorization Passes House
June 9, 2022
Novavax COVID-19 Vaccine Breezes Through Committee Thanks To FDA Case For Unmet Need; Manufacturing Review Is Final Obstacle To EUA
June 8, 2022
Prevision Policy Clips | FTC Launches Broad Study Of PBM Practices, Asking Top Six PBMS About Seven Different Topics
June 8, 2022
Bluebird’s Beti-Cel Thalassemia Gene Therapy: FDA Asking Committee How To View “Worrisome” Long-Term Safety Concerns In Face Of Clinical Benefit
June 8, 2022
Bluebird’s Eli-Cel For CALD: Complex Review Includes Cancer Risk Among Safety Concerns Mixed With Efficacy Interpretability Challenges Posed By FDA
June 7, 2022
CDER Workplace “Culture” Is Focus Of Retention Efforts After COVID; Re-Vamped “Equal Voice” Process Is One Step
June 7, 2022
Prevision Policy Clips | House Expected To Pass FDA User Fee Reauthorization Bill Today
June 7, 2022
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