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Prevision Policy Clips | Diversity Action Plan Guidance Clears OMB: FDA Implementation Of New FDORA Mandate Should Begin About Six Months Late
June 25, 2024
FDA Rare Disease “Innovation Hub” Is Born Out Of Cross-Center Agenda; CBER’s Marks Is Taking The Lead With Communication An Initial Focus
June 24, 2024
RWE-Only To Support A New Indication? "Yes, Potentially," FDA's Concato Says
June 24, 2024
Prevision Policy Clips | LDT Small Entity Compliance Guide Issued By FDA
June 24, 2024
N of 1? CBER’s Marks Again Overrules Staff In Granting Sarepta DMD Gene Therapy Label Expansion; One Last Regulatory Checkpoint Due In 2027 With ENVISION Trial
June 21, 2024
Prevision Policy Clips | Sarepta DMD Gene Therapy Label Expansion: CBER Director Marks Again Overrules Staff
June 21, 2024
Interchangeable For All? Switching Studies May Be Unnecessary For Interchangeable Biosimilar Designations, FDA Says In Draft Guidance
June 20, 2024
Advisory Committee Listening Session: Industry Mostly Sits Out FDA Feedback Meeting; AbbVie Registers Preference For Separate Documents, Elevated Patient Voice
June 20, 2024
Prevision Policy Clips | “Interchangeable” Biosimilar Guidance Update: FDA Says Switching Study Standards Have “Evolved”
June 20, 2024
Prevision Policy Clips | HHS OIG Allows Financial Assistance For Sickle Cell Gene Therapy In June 17 Opinion: Travel, Lodging, Meals, And Associated Expenses
June 18, 2024
CMMI Accelerated Approval Model May Not Advance “As Fast As Initially Proposed”; Sickle Cell Disease Model Has Received Letters of Intent From States Covering 80% Of SCD Patients
June 17, 2024
Prevision Policy Clips | CDER Artificial Intelligence Policy Lead Is Tala Fakhouri
June 17, 2024
CBER Office Of Therapeutic Products Leadership Trying To Increase Consistency Across Gene/Cell Therapy Reviews; Hiring Is Strong For Clinical, CMC Positions
June 14, 2024
Lilly’s Donanemab Positive FDA Panel Paves Way To Early Alzheimer’s Treatments; Tau Staging Not A Prerequisite
June 14, 2024
Prevision Policy Clips | FDA Recommends KP.2 Strain Vaccine For 2024-2025 COVID Vaccine Formula, Defying Advisory Committee Recommendation
June 14, 2024
“Onshoring” Solutions Are Not A Panacea For Drug Shortages, Generic Industry Cautions; Shift Towards Payment For Resiliency As Solution Evident At Duke Policy Meeting
June 13, 2024
Healthy Disagreement: FDA’s Califf Highlights Value Of Public Debate As Key To Advisory Committee Reform Push; Timeline For Changes Still Unclear
June 13, 2024
Prevision Policy Clips | Ultragenyx Will File Sanfilippo Syndrome Gene Therapy Application For Accelerated Approval
June 13, 2024
Prevision Policy Clips | BIOSECURE Act Path To Enactment Looks Less Secure
June 12, 2024
Prevision Policy Clips | Lilly Donanemab Alzheimer Treatment Gets Strong Efficacy And Benefit/Risk Endorsement
June 11, 2024
AI Use In Post-Market Safety: CDER Seeks “Mutual Learning” Under New Meeting Program; Up To Nine Projects Per Year Will Be Eligible
June 10, 2024
340B House GOP Bill Defines “Patient” And Requires Pass-Through Of Discounts; Subcommittee Hearing Features Bipartisan Interest In Fixes But Further Action Is TBD
June 10, 2024
Lykos’ Bad Trip To FDA Advisory Committee Leads To Rejection Of MDMA For PTSD; Psychedelic Therapeutic Era Not Ready To Begin Yet – But Meeting Offers Guideposts For Future Pathway
June 10, 2024
Prevision Policy Clips | AI Use For Post-Marketing Surveillance: FDA Accepting Requests For Meetings To Discuss
June 10, 2024
Lilly’s Donanemab Alzheimer’s mAb Receives Strong Efficacy Assessment From FDA; Potential In Populations Outside Formal Efficacy Trials Noted
June 7, 2024
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