Insights
Latest News and Insights
Practical writing on evidence, regulation, and market access
October 18, 2026
HEOR
ML-NMR in Practice: How Multilevel Network Meta-Regression Combines Patient-Level and Published Trial Data
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October 11, 2026
HEOR
Comparative Effectiveness Evidence for the Medicare Population: Building the Section I Case When the Trials Enrolled Younger Patients
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October 11, 2026
HEOR
Therapeutic Alternatives in Medicare Drug Price Negotiation: How CMS Identifies Them and How a Manufacturer Makes Its Case
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October 4, 2026
HEOR
Launch Prices After the IRA: What the JAMA Data Mean for Medicare Negotiation Evidence and US Dossiers
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October 4, 2026
HEOR
Budget Impact Analysis for India and the Gulf: Methods, Payer Requirements and Model Design
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October 4, 2026
HEOR
From NMA to Economic Model: Turning Relative Treatment Effects Into Cost-Effectiveness Model Inputs
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September 27, 2026
HEOR
NMA Feasibility Assessment: How to Decide Whether a Network Meta-Analysis Can Answer the Question
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September 27, 2026
HEOR
NMA, ITC, MAIC, STC or ML-NMR: Choosing the Indirect Comparison Method for an HTA Submission
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September 20, 2026
Market Access
CMS ICR Section I: Evidence About Alternative Treatments in Medicare Drug Price Negotiation
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September 14, 2026
Market Access
Medicare Drug Price Negotiation: Manufacturer Evidence, Negotiation Data Elements and How to Prepare
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September 13, 2026
Regulatory Affairs
IVDR GSPR Checklist: Annex I Requirements and Evidence Mapping
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September 11, 2026
Market Access
AMCP Format 5.0: A Guide to the US Formulary Dossier and Consultancy
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September 10, 2026
Regulatory Affairs
Biosimilars in 2026: The Global Landscape and the EvySaif Biosimilar Atlas, a Global Biosimilar Intelligence Platform
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September 6, 2026
Regulatory Affairs
Biosimilar Development in 2026: Regulatory Requirements, Evidence Planning and Market Access
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September 5, 2026
Medical Writing
Clinical Study Report (CSR): ICH E3 Structure, Content and the Writing Process
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September 4, 2026
HEOR
Network Meta-Analysis: A Practical Guide to Methods, Assumptions, Clinical Evidence and HTA Applications
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September 4, 2026
Regulatory Affairs
Drug Registration in UAE: The EDE Approval Process, Requirements, Pathways and Timelines
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September 2, 2026
Regulatory Affairs
CDSCO New Drug Approval in India: Process, Requirements, Documents and Timeline
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September 1, 2026
Regulatory Affairs
Drug Registration in India: CDSCO Approval Process, Requirements & Regulatory Strategy
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August 31, 2026
Regulatory Affairs
SFDA Medical Device Registration in Saudi Arabia: The 2026 Guide
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August 30, 2026
Regulatory Affairs
CDSCO Medical Device Regulations: The 2026 Guide to Classification, Licensing, and Market Entry in India
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August 23, 2026
Regulatory Affairs
The AYUSH Product Development Roadmap: From Classification to License in India
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August 23, 2026
Regulatory Affairs
CDSCO Import License for Medical Devices in India: MD-14, MD-15 and the Full Pathway
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August 19, 2026
Clinical Pharmacology
Pharmacokinetics and Pharmacodynamics: The Complete Guide to PK/PD Parameters, Studies, and What Regulators Expect
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August 13, 2026
IVDR
IVDR Technical Documentation in 2026: The Complete Guide and Checklist
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August 13, 2026
IVDR
IVDR Performance Evaluation and the PEP: How to Plan, Evidence, and Report It
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August 13, 2026
Digital Health
CDSCO's Final Medical Device Software Guidance: What It Says and What You Must Do
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August 13, 2026
Regulatory Affairs
Registering a New Medical Device in India with No Predicate: The Complete CDSCO Tutorial
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August 13, 2026
HEOR
The Global Value Dossier: Structure, Content, and a Worked Example
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August 13, 2026
Medical Writing
Clinical Study Report (CSR) Submission: Your Questions Answered
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September 10, 2025
Publications
Publication Ethics: Protecting Credibility, Preventing Retractions
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September 10, 2025
Medical Affairs
Case Study: Driving Stronger KOL Engagement
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July 18, 2026
HEOR
CHEERS 2022: Reporting Cost-Effectiveness Analyses That Pass Peer Review
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July 18, 2026
Regulatory Affairs
CDSCO Medical Device Registration in India: Classification, Licenses, and Timelines
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July 18, 2026
Medical Devices
How to Write a Clinical Evaluation Report Under EU MDR
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