Articles tagged with “fda-regulations”

Analyze the FDA's 2025 AI-driven enforcement of prescription drug advertising. This report details DTC compliance changes, warning letters, and pharma impacts.

Understand ICH Q7 GMP guidelines for active pharmaceutical ingredients (APIs). Review compliance requirements, quality management systems, and FDA regulations.

Learn how to deploy ChatGPT Enterprise in regulated GxP environments. This guide covers FDA compliance, 21 CFR Part 11, system validation, and data integrity.

Learn to validate AI vendor claims in pharma. This due diligence checklist covers GxP compliance, data security, and model performance verification methods.

Explore AI governance frameworks for pharmaceutical companies. Learn to align AI with GxP, FDA regulations, and data integrity standards for safe adoption.

A guide to applying ALCOA+ data integrity standards to AI and machine learning. Covers FDA compliance, data governance, and validation for regulated sectors.

Explore FDA 21 CFR Part 11 compliance for AI systems. This guide covers validation, audit trails, and data integrity for machine learning in GxP environments.

Learn why MSLs can discuss off-label data via scientific exchange while sales reps cannot, including FDA's 2023 SIUU guidance on firm-initiated scientific communications.

Updated 2026 guide to Structured Product Labeling (SPL) and data integrity. Covers FDA mandates, EMA ePI roadmap, Health Canada XML-PM, FHIR standards, and ALCOA+ compliance for pharmaceutical labeling.

Learn to write the Highlights of Prescribing Information (HPI). Updated for 2026 with AI labeling tools, the Prescription Information Modernization Act, and generic drug labeling reforms. Covers FDA requirements, PLR, and best practices.

This comprehensive 2025 guide details e-labeling (e-IFU) regulations worldwide. See our country-by-country analysis of QR code acceptance for medical devices &

Updated 2026 guide to FDA off-label promotion regulations for MSL teams, covering the January 2025 SIUU guidance, September 2025 OPDP enforcement surge, USPI boundaries, and compliance best practices

Learn what Investigator-Initiated Trials (IITs) are and the regulatory responsibilities clinicians face as a Sponsor-Investigator in academic clinical trials, including ICH E6(R3) GCP updates, EU CTIS requirements, and 2025-2026 regulatory changes.

This guide defines Fair Market Value (FMV) for clinical trial investigator compensation. Learn key regulations like the Anti-Kickback Statute and Stark Law to e

Compare ACRP vs. SOCRA clinical research certifications (updated April 2026). Covers ICH E6(R3) transition, eligibility, exam content, updated fees, and recertification for CCRC, CCRA & CCRP

Explore the distinct roles in clinical trials. Learn the specific responsibilities of sponsors, CROs, and sites, from protocol design to regulatory compliance u

Learn about 21 CFR Part 58, the FDA's Good Laboratory Practice (GLP) regulations for nonclinical studies. Updated for 2026 with recent enforcement actions, OECD IT security guidance, and New Approach Methodologies (NAMs)

An analysis of how Docusign (formerly DocuSign) is used for electronic signatures in pharma and life sciences. Learn how it can meet FDA 21 CFR Part 11 compliance with its Life Sciences modules and IAM platform, updated for 2026.

Updated 2026 guide for IT on 21 CFR Part 11. Covers FDA CSA guidance, AI compliance, electronic records & signatures, system validation, audit trails & data integrity

An analysis of the 2025 surge in new drug manufacturing plants from Eli Lilly, AstraZeneca & more. Learn about the key drivers: supply chain & geopolitics.

Explore US pharmaceutical automation compliance, covering FDA regulations like cGMP & 21 CFR Part 11, Pharma 4.0 trends, challenges, and best practices.

Learn how NetSuite ERP modules support U.S. pharmaceutical manufacturing labs, covering GMP, FDA (21 CFR Part 11) compliance, and integrations for quality and production. Updated for 2026 with NetSuite Next AI features and DSCSA compliance deadlines.

Learn about 21 CFR Part 11, the FDA regulation for electronic records and signatures. Updated for 2026 with the latest FDA guidance on electronic systems, Computer Software Assurance (CSA), and GAMP 5 Second Edition.

Explore Good Manufacturing Practice (GMP) in pharma. Learn its principles, global regulations, implementation, and compliance challenges for quality assurance.

Learn what Computer System Validation (CSV) is, its crucial role in pharmaceutical and biotech compliance, ensuring data integrity and regulatory adherence for patient safety.

In-depth guide to U.S. pharmaceutical marketing regulations: FDA, FTC, Sunshine Act, anti-kickback, compliance, and IT obligations for pharma companies.

An analysis of how artificial intelligence is transforming regulatory affairs in pharmaceuticals, from submission preparation to compliance monitoring and regulatory intelligence.

A detailed comparison of key compliance frameworks in pharmaceutical IT, including FDA 21 CFR Part 11, GDPR, HIPAA, and GxP, with implementation strategies and best practices.

A detailed exploration of Non-Personal Promotion strategies in pharmaceutical marketing, covering best practices, compliance requirements, and tools for effective HCP engagement without face-to-face interaction.