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FDA Accelerated Approval Council Will Not Review Contested Applications: Center Leadership Will Continue To Be Decision Maker, Agency Says In Response To IG Report
January 14, 2025
Prevision Policy Clips | Orphan Drug Designation Program Overview, Guide To Formatting And Assembling Requests Are Among 2025 Draft Guidance Priorities
January 14, 2025
FDA Cell/Gene Therapy Review Update: CBER’s Marks Says Team Is Doing “Pretty Well” But Things Could Change In Transition; OTP’s Verdun Praised By Industry Group
January 13, 2025
CAR-T Warning “Refinements” Coming Soon, FDA’s Marks Says, With Autoimmune Uses To Follow; Next Focus May Be Changes To Reduce Treatment Burden
January 13, 2025
Prevision Policy Clips | Part D/MA Proposed Payment Update Notice Released By CMS, Along With Draft Instructions For Implementing IRA Changes
January 13, 2025
FDA Off-Label Promotion Policy Re-Set: “Final” SIUU Guidance Is Out, But Full Implementation Awaits OMB Action – And Trump; Legal Memo Warns Of Threat To Pre-Market Review Authorities
January 10, 2025
FDA Disruption Begins? CDER Director Cavazzoni To Depart Before Inauguration Day
January 10, 2025
Prevision Policy Clips | Otsuka/Lundbeck Rexulti PTSD Indication Faces Delay And Uncertainty After FDA Decides An Advisory Committee Review
January 10, 2025
Tissue Biopsy Guidance Emphasizes Special Considerations For Pediatric Trials; FDA Builds On Pediatric Ethical Considerations Guidance To Set “Direct Benefit” Standard
January 9, 2025
Prevision Policy Clips | FDA AI Policy Head Tala Fakhouri Joins CBER Director Marks, OCE Director Pazdur Feb. 24 At The Biopharma Congress
January 9, 2025
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
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