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CAR-T Safety: CBER’s Marks Calms The Waters After Malignancy Alert, But FDA Likely To Want More Monitoring In Non-Oncology Setting
January 9, 2024
Prevision Policy Clips | Orphan Drug Label Expansion Analysis
January 9, 2024
NME Approvals In 2023 Back To Near-Historic Highs, But Some Signs Of COVID Fatigue May Be Showing Up At FDA
January 8, 2024
FDA Master Protocols Guidance Updates COVID-Focused Advice On Design Considerations; Trial Integrity A Key Concern
January 8, 2024
Prevision Policy Clips | FDA Commissioner Califf, CBER Director Peter Marks Discuss Vaccine Misinformation
January 8, 2024
Florida Rx Import Plan Approved By FDA, But Timing And Impact Remain Uncertain; Will First “SIP” Lead To Bigger Gulps?
January 5, 2024
FDA Advisory Committee Trends 2023: A Tale Two Halves — Fast Start Crashes To Halt; Uncertain Outlook Heading Into 2024
January 5, 2024
Prevision Policy Clips | Florida Rx Importation Plan Authorized By FDA: Approval Lasts For Two Years
January 5, 2024
Prevision Policy Clips | FDA’s Casgevy CRISPR Sickle Cell Gene Therapy Approval Included Four Pre-License Inspections
January 4, 2024
FDA’s Advice For Avoiding Clinical Holds In Gene/Cell Therapy Development: Pay Attention Early To Potency Assurance
January 3, 2024
Prevision Policy Clips | Geron’s Imetelstat For Myelodysplastic Syndrome To Get ICER Review In July
January 3, 2024
“Direct-To-Final” Guidances May Increase Under FDA Plan To Enhance Advice Process; Congressionally Mandated Report Notes Increase In Guidance Output Over Past Decade
January 2, 2024
Advisory Committee Tracker: The Lull Continues Into 2024
January 2, 2024
Prevision Policy Clips | Happy New Year? 17 Days Until Next FDA Shutdown Deadline
January 2, 2024
Prevision Policy Clips | Rare Disease Drug Development Guidance Finalized By FDA: Revisions Include Discussion Of Patient Input
December 22, 2023
Real-World Evidence Policy Taking Shape: FDA Finalizes Two More RWE/RWD Documents Along With Digital Health Tools Guidance As 2023 Draws To A Close
December 21, 2023
Prevision Policy Clips | Randomized Umbrella And Platform Trials Are Main Focus Of FDA Master Protocols Draft Guidance
December 21, 2023
Merck Sotatercept PAH Treatment Being Watched For Price Impact On Other Orphans; Dec. 1 ICER Meeting Confirms Clinical Benefits, Launch Price Concerns
December 20, 2023
Prevision Policy Clips | FDA Reissues COVID MAb Development Guidance To Support Ongoing EUAs
December 20, 2023
Adult ADHD Drug Development: FDA Awaiting Clinical Guidelines As Key Milestone; Seeks Balance To Ensure Appropriate Diagnosis Amid Shortages, Abuse Potential
December 19, 2023
Prevision Policy Clips | FDA/Industry Face-To-Face Meetings Will Expand To “All Meeting Types” Under PDUFA, BsUFA, and OMUFA Starting January 22
December 19, 2023
Prevision Policy Clips | Part B Inflation Rebates: 59 Different Drugs Owe Rebates In First Year
December 18, 2023
Cell/Gene Therapy Products Take Center Stage In Kick-Off Of CMS “New Technology” Payment Cycle; New Rules On FDA Status Reduce Number Of Candidates For FY25 NTAP “Town Hall”
December 18, 2023
Medicare Inflation Rebates: CMS Will Give 30 Days To “Suggest Errors” In First Rounds Of Invoices; Revised Guidance Provides Only Limited Relief For Most Drugs In Shortage
December 15, 2023
Prevision Policy Clips | FDA Formalizes Withdrawal Of AbbVie/J&J Imbruvica MCL/MZL Indications; ODAC Threat
December 15, 2023
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