Articles tagged with “fda-guidance”

Compare FDA's Computer Software Assurance (CSA) vs CSV for AI systems. Learn risk-based validation strategies for machine learning in life sciences.

Analyze the transition from CSV to FDA's Computer Software Assurance (CSA). This guide details risk-based validation strategies and compliance impacts.

Learn cybersecurity requirements for AI medical devices. Covers FDA guidance, EU regulations, SBOM mandates, and defenses against adversarial AI attacks.

Learn the key differences in regional eCTD submission guides from the FDA, EMA, & Health Canada. This guide covers Module 1 variations and the shift to eCTD v4.

Learn the compliant process for answering off-label HCP inquiries. This guide details FDA guidance, medical information SOPs, and software for case management.

Learn what must be included in a pharma quality agreement. This guide covers key clauses, sponsor vs. CDMO responsibilities, and GMP regulatory requirements fro

Learn the lifecycle approach to biotech process validation. This guide covers PPQ and CPV planning, execution, and monitoring based on FDA, EMA, and ICH guidanc

Learn how Generative AI (GenAI) applies to Medical Affairs in pharma. This guide covers key use cases, compliance guardrails, and the risks of using LLMs.

Learn about the FDA's AI guidance for drug development. This article explains the 7-step credibility framework, context of use (COU), and risk-based approach.

Understand the FDA's final Computer Software Assurance (CSA) guidance, a risk-based shift from CSV for pharma & biotech. Learn key principles for compliance.

Learn how to integrate GAMP 5 (2nd Ed.) and Computer Software Assurance (CSA). This guide details the shift from CSV to a modern, risk-based validation strategy

Learn how generative AI and LLMs assist in drafting pharma IND & CTA submissions. This guide explains the benefits, risks, GxP compliance, and FDA/EMA guidance.

A guide to the Target Product Profile (TPP), a strategic document for drug development. Learn its components, purpose, and how to align it with the final drug l

An in-depth guide to adaptive trial design. Learn how prespecified changes based on interim data can make clinical trials more efficient and ethical.

Learn how to manage protocol deviations in clinical trials. This guide covers classification, reporting, and prevention to ensure data integrity and GCP complia

Learn the 9 ALCOA+ principles for GxP data integrity. This complete guide explains each attribute, FDA & EMA regulations, and compliance for pharma and life sci

Analysis of AI medical devices in 2025. Learn about market growth, 950+ FDA-cleared devices, new regulations like the EU AI Act, and key clinical challenges.

A practical guide to clinical trial phases 1–3 for pharma IT: objectives, compliance, costs, and IT infrastructure for modern drug development.