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

FDA Aims To Streamline Drug Delivery Device Development In New Guidance Detailing Process For Establishing Essential Drug Delivery Outputs (EDDOs)

Prevision Policy Clips | Another Supreme Court Ruling Will Impact FDA Regulation: Statute Of Limitations Decision

FDA After Chevron: Immediate Changes Unlikely; More Litigation And Fewer Regs May Follow; CMS Pricing Policies May Have Bigger Impacts

Prevision Policy Clips | Cisplatin Shortage “Resolved,” FDA Reports June 27

Real-World Evidence In NDA Reviews: FDA Reports Four Approvals Supported By RWE In FY23; Dose Modification For UCB’s Vimpat Is Rare Case Of RWE As Main Evidence

Advisory Committee Tracker: AstraZeneca Imfinzi sBLA Will Test FDA’s “How Much Is Enough?” Concerns At ODAC; Committee Meetings Still Lagging In 2024

Prevision Policy Clips | Medicare Oral Phosphate Binder Payment Shift Will Increase Spending By $180 Million In 2025, CMS Says

Medicare Coverage Of Obesity Drugs: “First Step” May Be Access For Current Users Who Join Program; Narrow House Bill Moves Forward Amid Calls For Price Scrutiny

Getting “Digital Endpoints” Right: Clinical Goals Should Drive Technology Development – Not The Other Way Around, FDA’s Sacks Tells FNIH Workshop

Prevision Policy Clips | Medicare Weight Loss Drug Coverage Bill Heads To Mark-Up June 27: Modified House Bill

Diversity Action Plan Guidance: FDA Wants DAPs By End-Of-Phase II Meeting, Says Waivers Will Be Rare; Requirement On Track To Kick In For 2026

Prevision Policy Alert: FDA Posts Diversity Action Plan Draft Guidance

Prevision Policy Clips | BIOSECURE Act Is Budget Neutral, CBO Reports

Prevision Policy Clips | Diversity Action Plan Guidance Clears OMB: FDA Implementation Of New FDORA Mandate Should Begin About Six Months Late

FDA Rare Disease “Innovation Hub” Is Born Out Of Cross-Center Agenda; CBER’s Marks Is Taking The Lead With Communication An Initial Focus

RWE-Only To Support A New Indication? "Yes, Potentially," FDA's Concato Says

Prevision Policy Clips | LDT Small Entity Compliance Guide Issued By FDA

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

Prevision Policy Clips | Sarepta DMD Gene Therapy Label Expansion: CBER Director Marks Again Overrules Staff