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Prevision Policy Clips | FDA Appears Ready to Approve Ferring/Seikagaku’s Condoliase But Wants To Ensure Appropriate Use
January 8, 2025
Ferring/Seikagaku’s Condoliase Advisory Committee Review Aims To Avoid Repeating History; FDA Appears Ready To Approve Radicular Pain Treatment But Wants To Ensure Appropriate Use
January 7, 2025
FDA Guidance Recommends Robust Characterization, Investigation Of Sex-Related Differences In Medical Product Research
January 7, 2025
FDA Draft Obesity Guidance Updated For GLP1 Era: Affirms Obesity As A “Disease,” But Keeps Primary Efficacy Requirements Largely Unchanged; CV Safety Expectations Outlined
January 7, 2025
Prevision Policy Clips | FDA Updating Obesity Drug Development Guidance For GLP-1 Era
January 7, 2025
AI In Drug Development: FDA “Credibility Assessment” Framework Emphasizes Context Of Use; Agency Wants Feedback On Whether Current Engagement Options Are “Sufficient”
January 6, 2025
The New Rules Of Accelerated Approval: FDA Draft Guidance Defines Standards For Assuring Confirmatory Trials Are “Underway”; Some Flexibility For Rare Diseases
January 6, 2025
Prevision Policy Clips | FDA Guidance Dump: 25 Guidances Announced January 6
January 6, 2025
Trump II Impact On FDA: Reviewers Will Feel Pressure Across The Board But Office Of Neuroscience, CBER May Face Most Impact; OCE Could Be Unscathed
January 3, 2025
FDA Advisory Committee Trends: Just 14 Applications Reviewed In 2024; Rejection Rate Also Goes Back Up From 2023
January 3, 2025
Prevision Policy Clips | CBER Plans Guidance On Post-Approval Safety And Efficacy Data For Cell/Gene Therapies
January 3, 2025
FDA May Accept “Similar” Submissions For Advanced Manufacturing Technology Designation Program, Final Guidance Says
January 2, 2025
Advisory Committee Tracker: Opioid Response Is Early 2025 Focus For FDA; Novartis Fabhalta sNDA Set For February Review
January 2, 2025
CMS Seeking “More Concise” Submissions For New Technology Add-On Payment Candidates; FY 2026 Cycle Kicks Off With 13 Drug/Biologic Products Seeking Enhanced Medicare Payment
January 2, 2025
Prevision Policy Clips | FDA “Point/Counterpoint” Draft Guidance Suggests Sponsors Can Decide
January 2, 2025
FDA Protocol Deviation Draft Guidance Urges Patient-Friendly Trial Designs To Minimize Deviations, Offers Examples Of “Important” Deviations
December 31, 2024
ODAC “Point/Counterpoint” Shared Briefing Document Formalized Via Draft Guidance; FDA Indicates Sponsor Chooses Approach, Invites Requests For Non-Oncology Products
December 31, 2024
Prevision Policy Clips | FDA Finalizes Advanced Manufacturing Technology Designation Program Guidance
December 31, 2024
“ACNU” Nonprescription Drug Safe Use Rule Finalized By FDA; Simultaneous Rx Marketing Would Be Permitted, If Rule Survives Trump Transition And Judicial Review
December 30, 2024
Prevision Policy Clips | FDA Shutdown Averted, But Pediatric PRV Program In Limbo
December 30, 2024
Prevision Policy Alert: FDA Shutdown Averted, But Pediatric PRV Program In Limbo
December 23, 2024
Prevision Policy Clips | Government Shutdown Clock Is Ticking: House Again Fails To Pass A Continuing Resolution
December 20, 2024
FDA Drug Shortage Provisions Left Out Of Proposed PAHPA Reauthorization Plan; “Lame Duck” Uncertainty Jeopardizes Prospects For Program
December 19, 2024
Prevision Policy Clips | “Lame Duck” Reset: Trump, “DOGE” Torpedo Bipartisan Continuing Resolution
December 19, 2024
Commissioner Califf’s Message On Setting R&D Priorities: Leave FDA Out Of It; National Academy Event Is Forum For Outgoing Commissioner To Reflect, Reiterate Key Themes
December 18, 2024
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