Prevision Policy Clips | Democratic Campaign Shakeup Means New President Will Appoint Next FDA Commissioner

OCE’s Lucky Seven (Years): Oncology Reviewers Reflect On Center’s Success, Name Assessment Aid And “Project Facilitate” As Favorite Programs

Prevision Policy Clips | Ardelyx Sues CMS To Block Xphozah Payment Change

Working Toward An FDA Rare Disease Center: “Hub” Locks In Compromise Approach For Now

Prevision Policy Clips | FDA Formally Unveils “Rare Disease Innovation Hub”; CDER Seeks New Associate Director For Rare Disease Strategy

FDA Approval Decisions May Face Legal Challenges Post-Chevron – But Not In The Near Term, Legal Analysts Suggest

GeMDAC Starts Small: Four Members Named To FDA’s Newest Advisory Committee Ahead Of Inaugural Meeting; Six Vacancies Remain

Prevision Policy Clips | Genetic Metabolic Diseases Advisory Committee: FDA Announces First Four Members

FDA Appropriations Bills Point Towards Flat Funding; House And Senate Committees Show Interest In Accelerated Approval, DEA Scheduling, Psychedelics, And Drug Shortages

Prevision Policy Clips | FDA Extends Platform Technology Designation Guidance Comment Period To Aug. 28

Prevision Policy Clips | Partial-Onset Seizure Therapeutics: FDA Revises Guidance To Include Efficacy Extrapolation From Adults To Infants

Prevision Policy Clips | BIOSECURE Act Path To Enactment Taking Shape: Senate May Attach House Version To Defense

Medicare Inflation Rebate Reconciliation Process Added In Regulatory Codification; CMS Proposes To “Estimate” 340B Units For Part D Rebate Exclusion

Prevision Policy Clips | Senate FDA Appropriations Bill Gives FDA $22 Million Increase

Prevision Policy Clips | “Big Three” PBMs Reportedly To Testify At House Oversight Committee Hearing July 23

Drug/Device Combos: FDA Use-Related Risk Analysis Guidance Fleshes Out Agency’s Thinking On Best Approaches To URRAs As Guide For Human Factor Studies

FTC “Interim” Report On PBMs Includes Call For Further Attention To “Exclusionary” Rebates That Block Generics/Biosimilars; Are PBMs Too Big To Understand?

Prevision Policy Clips | Zevra Arimoclomol Resubmission Will Be First Review By FDA Genetic Metabolic Diseases Advisory Committee

FDA Misinformation Guidance: “Tailored Responsive Communications” Would Have Safe Harbor Under New Draft; Greater Ability For Firms To Respond Online

Cancer Drug Tolerability: FDA Developing Framework For Symptom Selection To Support PRO Collection By Sponsors

Prevision Policy Clips | FDA Misinformation Guidance: “Tailored Responsive Communications” Is New Category Of Sponsor Communication

Prevision Policy Clips | Post-Marketing Surveillance With Real World Data: FDA Opens Comment Period On ICH Guidance

CBER Guidances On Rare Disease Gene Therapy Accelerated Approval, CRISPR As “Platform” Added To 2024 Agenda

Prevision Policy Clips | Lilly Kisunla (Donanemab) Clears FDA For Alzheimer’s: Early Dosing Cutoff

Sickle Cell Gene Therapy Model: States Will Need To Provide Assurance Of Access To Participate In CMMI Demo; “Streamlining” Emphasized Over Pricing In RFA