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

September 20, 2023

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

September 20, 2023

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

September 19, 2023

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

September 19, 2023

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

September 19, 2023

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

September 19, 2023

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

September 19, 2023

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

September 18, 2023

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

September 18, 2023

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For All NASH Drugs, Immunogenicity Labeling Required For All Peptide Drugs, FDA Says In Clinical Pharmacology Draft Guidance

September 15, 2023

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

September 15, 2023

Prevision Policy Clips | Biosimilar/Interchangeable FDA Labeling Draft Guidance Builds On Earlier General Principles

September 15, 2023

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

September 14, 2023

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

September 14, 2023

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

September 13, 2023

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

September 13, 2023

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

September 12, 2023

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

September 11, 2023

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

September 11, 2023

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

September 11, 2023

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

September 8, 2023

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

September 8, 2023

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

September 7, 2023

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

September 7, 2023

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

September 6, 2023
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