🔹 FDA & Regulatory Guidance
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OPDP Untitled Letters Archive
Examples of promotional violations since 1997
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FDA AI in Regulatory Decision-Making – Draft Guidance (2025)
Covers AI validation, transparency, data integrity, and human oversight in submissions
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CDER AI for Drug Development Hub
FDA resource on AI use across the drug lifecycle
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🔹 Peer-Reviewed & Academic Literature
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Global GMP & AI Frameworks
Analysis of FDA/EMA/WHO perspectives on AI validation, ethics, and audit trails
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AI Across the Drug Lifecycle
Explores AI’s role in clinical development, regulatory approvals, and post-market surveillance
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Comparative AI Regulation: US, EU, Global
Highlights evolving international frameworks
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🔹 Market Access, HTA & Real-World Evidence
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Real-World Evidence for Payers
Barriers to RWE adoption by payers
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Intro to HTA & Cost-Effectiveness
Covers QALY, decision thresholds, and global HTA methodology
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Accelerated Device Approvals: FDA vs. EU
Comparison of BDP, TCET, MDR pathways (relevant to medtech market entry strategy
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🔹 RWE in Action
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RWE in Clinical Trials (Quanticate)
Case examples of label expansions using RWE
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The REVEAL Study
Review of RWE integration in pre-marketing strategies
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🔹 Digital Health & AI Adoption Barriers
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Clinician Barriers to Digital Health
Systematic review of adoption hurdles
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Adoption Friction in Health Tech
Explores reimbursement blockers, and value-based care misalignment
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🔹 AI & Compliance Whitepapers
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AI in Regulatory Affairs & QA (IQVIA)
Covers automation in submissions and QA
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AI in Market Access (Eularis)
How AI enables faster, evidence-led pricing and reimbursement decisions
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AI in PRMA (Life Sciences Dynamics)
Tracks emerging AI applications in pricing and reimbursement strategy
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Market Access Analytics (Intuition Labs)
Overview of scenario modeling, NLP, and advanced analytics for payer negotiation
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🔹 Commercialization & Go-To-Market
Commercialization Framework (LinkedIn)
Step-by-step roadmap from R&D through GTM, tailored for medtech and biotech firms
Biotech Launch Case Study (Flevy)
Details launch acceleration and market share growth via regulatory optimization
EndemicEase Vaccine Regulatory Walkthrough
Real-world IND-to-approval blueprint
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Selling Into Hospitals (Storm Ventures)
Practical GTM strategy for healthtech/medtech
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🔹 Patent & Lifecycle Strategy
Patent Cliff Strategy (PMC)
Outlines extension tactics
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The Patent Cliff Playbook
Advanced guide to exclusivity loss management, biosimilars, and litigation
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🔹 VC & Funding Trends
2024–2025 VC Reports: Health Tech & AI
HSBC, Paragon, Rock Health, and others on AI-health deal flow and Series B gaps
AI Biotech Mega-Rounds (Intuition Labs)
Analysis of capital-efficient biotech models and team structures
Canada Life Sciences VC Landscape (DEEP Centre)
Outlines funding bottlenecks and scaling pathways in the Canadian ecosystem
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🔹 Sectoral Insights & Policy
McKinsey: AI in Payer Transformation
How payers can capture $150M+ in cost savings via AI
Health Technology Assessment (HTA) Primer
Foundational guide to HTA principles and global application