Pharmaceutical Industry Articles & Reports - Page 5

Learn how Veeva RIM automates end-to-end pharmaceutical labeling. This guide explains 5 core workflows for label change management and regulatory compliance.

Get a 6-month checklist for pharmaceutical labeling operations. This guide covers key steps for regulatory approval, FDA/GMP compliance, and avoiding costly del

Learn how Veeva PromoMats' Auto-Update Anchors feature automates marketing claims substantiation to ensure regulatory compliance and reduce manual MLR review ef

A guide to Reference Safety Information (RSI) in clinical trials. Learn the regulatory framework, common pitfalls, and how to avoid SUSAR reporting errors.

Learn why Structured Product Labeling (SPL) is replacing PDF for pharma labeling. This guide explains the FDA mandate, XML standards, and how SPL ensures data i

Explore the regulatory process for negotiating an FDA boxed warning on drug labeling, from initial NDA review to post-market Safety Labeling Changes (SLCs).

Learn to write the Highlights of Prescribing Information (HPI). This guide covers FDA labeling requirements, the Physician Labeling Rule (PLR), and best practic

Learn how the FDA's PLLR replaced old pregnancy categories. This guide explains how to draft clear pregnancy risk summaries for complex biologics with limited d

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

An evidence-based review of NLP in regulatory labeling. Learn how AI assists medical writers in drafting Prescribing Information (PI/SmPC) and its limitations.

A comprehensive guide to transitioning from XML-based SPL to HL7 FHIR for e-labeling. Learn the key benefits, regulatory requirements, and steps for team readin

Learn the FDA regulations for off-label promotion and how MSL teams can maintain compliance. This guide covers USPI boundaries and best practices for scientific

Learn how simple pharmaceutical translation errors in an SmPC or patient leaflet can lead to major drug recalls, regulatory sanctions, and patient safety risks.

Explore a structured cascade model for rolling out pharma safety labeling updates to global affiliates, ensuring regulatory compliance and sub-90-day implementa

An analysis of Google's Gemini 3 AI for healthcare, pharma, and biotech. Learn about its multimodal reasoning, agentic features, and applications in drug discov

Learn the difference between a Company Core Data Sheet (CCDS) and local labels. Explore strategies for managing global labeling deviations for regulatory compli

Learn the definitions and key differences between basket, umbrella, and platform trials. This guide explains how master protocols work in precision oncology.

Learn the key differences between ISO 14155 for medical device trials and ICH GCP for pharma. This guide compares their scope, risk management, and regulatory c

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 what Investigator-Initiated Trials (IITs) are and the regulatory responsibilities clinicians face as a Sponsor-Investigator in academic clinical trials.

An educational guide to sample size calculation in clinical trials. Learn the roles of statistical power, effect size, and alpha/beta errors in trial design.

An analysis of cell and gene therapy logistics for clinical trials, covering supply chain challenges like the cryogenic cold chain, chain of identity, and trace

Explore the Bid Defense Meeting (BDM), a critical step for CROs to win clinical trial contracts. Learn key preparation strategies, sponsor criteria, and best pr

Explore the rise of CRO consolidation in the clinical trials industry. This analysis covers M&A trends, key drivers, and the impact on pharma sponsors and quali