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Prevision Policy Clips | Pfizer Pentavalent Meningococcal Vaccine Recommendation Vote Set For Upcoming ACIP Meeting Oct. 25-27
September 26, 2023
BrainStorm NurOwn For ALS: Negative Review From FDA Draws A Line For Advisory Committee After Unprecedented Flexibility For Other Agents
September 25, 2023
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
September 25, 2023
FDA Unveils “Preliminary” Postapproval Pregnancy Safety Study Framework; Stakeholders Urge Greater Flexibility, Adaptive Study Designs
September 25, 2023
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
September 25, 2023
Prevision Policy Clips | Shutdown Math: Over 80% Of FDA Staff Would Be Spared
September 25, 2023
Price Negotiation Hearing Highlights Industry Push To Extend Small Molecule Lifespan; Broader Orphan Exemption Also Raised
September 22, 2023
NASH/MASH Surrogate Endpoints: FDA Urges Biomarker Developers To Rethink Approach, Work Together On Alternatives To Histology; “Quantum Of Benefit” Is One Key Theme
September 22, 2023
Prevision Policy Clips | Biomarkers For Allergic Diseases And Asthma FDA Workshop February 22
September 22, 2023
Intarcia/i2O ITCA 650 Diabetes Combo Rejected In Unusual “Refuse To Approve” Hearing; FDA Panel Sees Too Many Risks Linked To Inconsistent Device
September 22, 2023
“Hybrid” Pre-Approval Inspections Will Be Part Of FDA Practice Post-COVID; Draft Guidance Outlines Plan To Continue Flexibility In Using Alternatives To Traditional PAIs
September 21, 2023
Prevision Policy Clips | Preapproval Inspection Alternatives: FDA Draft Guidance Outlines “Risk-Based Approach”
September 21, 2023
Biosimilar Clinical Study Streamlining: Regulatory Mindset Is Changing, But FDA Policy Updates Will Likely Come At Measured Pace In Context Of Global Harmonization
September 20, 2023
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
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