Global Health in the Age of AI
This whitepaper discusses the implications of AI on global health inequalities and proposes a coordinated approach to address these challenges.
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Transform Downstream Processing with an Integrated Solution
This whitepaper discusses an innovative inline buffer formulation system that optimizes biomanufacturing processes.
Examining the Validity of External Controls Relative to Randomized Controls
This presentation discusses the validity of external controls in medical product development and their comparison to randomized controls.
FDA Draft Guidance on AI in Drug Development Explained
This whitepaper analyzes the FDA's draft guidance on AI in drug development, detailing its implications for industry practices and regulatory compliance.
A dataset of digital therapeutic device approvals to support regulatory decisions and industry research
This paper presents a comprehensive dataset of digital therapeutic device approvals across four countries to aid regulatory decisions and industry analysis.
Radiopharmaceuticals - EU-IN Horizon Scanning Report
This report outlines the current status, trends, and regulatory challenges in the field of radiopharmaceuticals in the EU.
Cytological Specimens in the Molecular Era of Metastatic Melanoma
This whitepaper discusses the role of cytological specimens in diagnosing metastatic melanoma and their implications for precision oncology.
🔒 ASHP Policy Positions 1982-2026
A comprehensive catalog of professional policy positions by ASHP, advocating for pharmacy practice and public health.
🔒 Announcement of Calendar Year (CY) 2027 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies
This whitepaper outlines the Medicare Advantage capitation rates and payment policies for 2027, emphasizing stakeholder feedback and risk adjustment strategies.
🔒 The 2024 EU GMP Annex 1 Revision: A Technical Roadmap for Holistic Contamination Control and Quality Risk Management in Sterile Manufacturing
This review discusses the 2024 revision of EU GMP Annex 1, focusing on contamination control and quality risk management in sterile manufacturing.
🔒 Scientific Standards for 23andMe's Health and Trait Reports
This white paper outlines the scientific standards for 23andMe's genetic health and trait reports, emphasizing validity and evidence-based practices.
AESGP Position on Commission Proposal for Simplification of MDR
This position paper outlines AESGP's recommendations on simplifying medical device regulations in Europe.
Futureproofing Post Approval Compliance by Integrating LQPPV and Lifecycle Management with Applied AI
This whitepaper discusses strategies for enhancing post-approval compliance in pharmaceuticals through integrated governance and AI.
Overview of Comments Received on ICH Q3E Guideline
This document summarizes comments on the ICH Q3E Guideline regarding extractables and leachables, focusing on regulatory and safety considerations.
Strengthening the FDA's Accelerated Approval Pathway: Progress and Unfinished Business
This whitepaper reviews the FDA's Accelerated Approval pathway, highlighting its evolution, challenges, and proposed reforms.