Oncology Multi-Agent Dosing Strategies: Sponsors Can Learn From Other Drug Classes; Anesthesiology Offers Way To Understand Efficacy/Toxicity

Prevision Policy Clips | “Infected Trials” Guidance Reissued By FDA: COVID Advice On Disruptions Will Carry-Forward

NASH/MASH Accelerated Approval: FDA Remains Confident In Pathway For Liver Disease; Confirmatory Trials Difficult, But Doable, FDA Officials Say During Biomarker Workshop

Intarcia/i2O ITCA 650 “Refuse To Approve” Hearing Draws Out FDA Concerns Over Device Component, Safety; Committee Likely To Agree With Agency

When One Trial Is Enough: FDA Expands On Options For Confirmatory Efficacy Evidence, Including RWE, Expanded Access

Prevision Policy Clips | FDA Changes Therapeutic Equivalence Rating For Accord Healthcare’s Tacrolimus Generic

OTP Director Verdun Outlines “Opportunity” For Gene Therapy “Platform” Technologies, Shares CBER Head Marks’ Vision For Moving Field Forward

House Generic Drug Shortage Hearing Shows Discord Over Rebate Incentives, FDA’s Role As Instigator; Are “Buffer Stocks” A Bipartisan Solution?

Prevision Policy Clips | FDA Single Trial Efficacy Guidance Details “Types Of Evidence” That Could Be Considered Confirmatory

Hepatic Impairment Studies Recommended For All NASH Drugs, Immunogenicity Labeling Required For All Peptide Drugs, FDA Says In Clinical Pharmacology Draft Guidance

Cell/Gene Therapy Is Ripe For RWD Given Length Of Follow-Up Required, Abernethy Says; Informed Consent Will Need To Evolve For New Data Needs

Prevision Policy Clips | Biosimilar/Interchangeable FDA Labeling Draft Guidance Builds On Earlier General Principles

Alnylam’s Onpattro For Cardiomyopathy Secures Cardio-Renal Advisory Committee Recommendation On “Light Wind” Of Benefit, No Risks

Prevision Policy Clips | FDA Office Of Immunology And Inflammation Acting Deputy Director Is Kathleen Donohue

Prevision Policy Clips | CMS Acting Chief Medical Officer Dora Hughes To Testify At House Energy & Commerce Health Subcommittee Hearing Sept. 19

ORA Reorg To Include Inspectors Trained In Real-World Evidence, FDA’s Califf Says; Commissioner Pushes RWE To Guide Use Of Alzheimer’s, Obesity Drugs

Prevision Policy Clips | FDA Commissioner's Senior Clinical Advisor For Chronic Disease Is Brigham & Women’s Cardiologist Haider Warraich

Alnylam Onpattro For ATTR-CM: FDA Seeking Cardio-Renal Committee View On Extent Of “Clinically Meaningful” Effect; FDA Review Team Not Convinced

Prevision Policy Clips | Regeneron “Substantially Equivalent” Ex-US Pricing Clause In Project NextGen Agreement Leads To NIH Pick Bertagnolli Confirmation Hearing In October

Dose Optimization In Oncology Drug Combinations: “Dosing Toolkit” Is Next Step In “Project Optimus” To Prepare Sponsors For Filing And Avoid Review Delays

Real-World Views On RWE: RECOVER Trial On Long COVID Seen As US Answer To UK’s RECOVERY; Data Sources Are Ongoing Challenge To RWE Trial Interpretation

Prevision Policy Clips | Generic Drug Shortages Legislative Hearing In House Energy & Commerce Health Subcommittee Scheduled For September 14

FDA Human Factors Studies Guidance Finalized With New Name And Format; FDA Clarifies “Critical Tasks,” With Emphasis On Mis-Dosing, Time Sensitivity

Prevision Policy Clips | Merck Chronic Cough Drug Gefapixant Will Go To FDA’s Pulmonary-Allergy Drugs Panel November 17

CMS Resists Role As Rebate Monitor During IRA Transition: GAO Report Confirms Diabetes, Blood Thinners As Highly Rebated Classes In Part D