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FDA Platform Technology Effort Occurring At Opportune Time: Gene Editing Advances May Allow FDA To Be More Ambitious With Pathway
May 6, 2024
Prevision Policy Clips | OCE “Project 5-In-5”: FDA Oncology Center “Crowdsourcing” Five Pragmatic Oncology Trial Ideas
May 6, 2024
Price Negotiation Year 2: Lower Prices And Fewer Meetings? CMS Draft Guidance Tweaks Price-Cutting Process In Anticipation Of More Drugs And Tighter Timelines
May 3, 2024
Prevision Policy Clips | Price Negotiation Year 2: Manufacturers Will Have Mid-December Deadline To Request Exemptions
May 3, 2024
Prevision Policy Clips | Schizophrenia Drug Development: FDA Meeting On Approaches To “Negative Symptoms”
May 2, 2024
Prevision Policy Clips | “Reshoring” Drug Production: DoD Pressed To Do More
May 1, 2024
FDA Advisory Committee “Listening Session”: Stakeholder Outreach Unlikely To Prompt Major Changes; Fighting Misperceptions Is One Theme
April 30, 2024
Advisory Committee Tracker: Novo Once-Weekly Insulin Will Head To Committee In May; Donanemab, Ocaliva Reviews In The Works
April 30, 2024
FDA Quantitative Medicine Center Aims To Move Drug Development Move Away From “Ad Hoc” Use Of Modeling And Simulation; OCP’s Madabushi Is First Director
April 30, 2024
FDA OCE Questions “Unnecessarily Restrictive Eligibility Criteria” With Three New Guidances On Lab Values, Washout Periods, And Performance Status
April 30, 2024
Prevision Policy Clips | Public “Persistent Misconception” Of FDA Advisory Committees One Topic For Discussion
April 30, 2024
LDT Final Rule Takes Lighter Touch: Existing Tests Will Be “Grandfathered” But Subject To More FDA Scrutiny; New Versions Will Be Subject To Pre-Market Review
April 29, 2024
What If Trump Wins? Risk Of FDA Departures, But Maybe “Shaking The Tree Wouldn’t Be A Bad Thing”: CMS Models Would Continue; Jindal For HHS?
April 29, 2024
Prevision Policy Clips | Cell/Gene Therapy CMCs: CBER Guidance Addresses Unique Issues
April 29, 2024
Prevision Policy Clips | Novo Nordisk Once-Weekly Insulin Icodec Subject Of FDA Advisory Committee May 24
April 26, 2024
Prevision Policy Clips | FDA Cancer Trial Eligibility Guidances Seek Broader Inclusion Criteria In Three Areas
April 25, 2024
CBER Gene Therapy Office Likely To Need More Staff In Coming Years; Strategic Planning Will Be Critical For Evolution Of Hybrid Work, Director Marks Says
April 24, 2024
Prevision Policy Clips | CBER “Focus On The Patient” Initiative Coming Soon, Director Peter Marks Says
April 24, 2024
CBER Gene Therapy Accelerated Approval Guidance Will Describe Three Scenarios Based On Biomarkers, Marks Says; CRISPR “Platform” Guidance Also Planned
April 23, 2024
Prevision Policy Clips | LDT Final Rule Coming Soon? FDA Lab Developed Test Regulation Cleared By OMB “Consistent With Change”
April 23, 2024
Prevision Policy Clips | FDA Annual Postmarket Requirements/Commitments Report For FY 2022 Likely To Focus On Number Of Overdue PMRs
April 22, 2024
Generic Drug Supply Chain Complexity Could Complicate Proposed Shortage Solutions, MedPAC Commissioner Suggests; New Pricing Data Underscore “Variability”
April 19, 2024
340B Pricing Averages ASP-29% For Part B Hospitals, MedPAC Data Show; Commission Disclaims Immediate Policy Agenda
April 19, 2024
Prevision Policy Clips | Gene Therapy BLA CMC Readiness Is Subject OTP Town Hall
April 19, 2024
HHS Inter-Agency Real-World Data Registry Collaboration Underway; NIH Looking Separately To Collaborate With FDA In The Post-Market
April 18, 2024
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