Prevision Policy Clips | Pfizer Pentavalent Meningococcal Vaccine Recommendation Vote Set For Upcoming ACIP Meeting Oct. 25-27

BrainStorm NurOwn For ALS: Negative Review From FDA Draws A Line For Advisory Committee After Unprecedented Flexibility For Other Agents

FDA Staff Mostly Spared From Shutdown: 81% Of Agency Employees Would Be Retained In Funding Lapse; CMS Would Face Deeper Cuts, But Likely Not In Price Negotiation Team

FDA Unveils “Preliminary” Postapproval Pregnancy Safety Study Framework; Stakeholders Urge Greater Flexibility, Adaptive Study Designs

FDA “Digital Labeling” Guidance Affirms That Most Drug Use-Related Software Does Not Require Prior Approval; “Direct Transfer” Of Information From Product Is Key Consideration

Prevision Policy Clips | Shutdown Math: Over 80% Of FDA Staff Would Be Spared

Price Negotiation Hearing Highlights Industry Push To Extend Small Molecule Lifespan; Broader Orphan Exemption Also Raised

NASH/MASH Surrogate Endpoints: FDA Urges Biomarker Developers To Rethink Approach, Work Together On Alternatives To Histology; “Quantum Of Benefit” Is One Key Theme

Prevision Policy Clips | Biomarkers For Allergic Diseases And Asthma FDA Workshop February 22

Intarcia/i2O ITCA 650 Diabetes Combo Rejected In Unusual “Refuse To Approve” Hearing; FDA Panel Sees Too Many Risks Linked To Inconsistent Device

“Hybrid” Pre-Approval Inspections Will Be Part Of FDA Practice Post-COVID; Draft Guidance Outlines Plan To Continue Flexibility In Using Alternatives To Traditional PAIs

Prevision Policy Clips | Preapproval Inspection Alternatives: FDA Draft Guidance Outlines “Risk-Based Approach”

Biosimilar Clinical Study Streamlining: Regulatory Mindset Is Changing, But FDA Policy Updates Will Likely Come At Measured Pace In Context Of Global Harmonization

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