Newsletter | July 17, 2025

07.17.25 -- Composition Statements Of Ingredients In Labeling In NDAs And ANDAs

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Slow The Burn: How To Make Risk-Resilient Vendor Choices

Discover how to spot the most common red flags when selecting a CRO and avoid costly setbacks in your clinical program. Gain expert strategies to strengthen contracts, improve vendor accountability, and protect your budget.

OUTSOURCING

How AI And Secondary Data Use Are Changing The Way We Do CTAs, Part Two

Leibowitz Law experts examine how tech developments affect key CTA provisions and provide practical, technology-inspired updates for your clinical trial agreements. Part two covers the secondary use of study data and AI.

What ASCO 2025 Means For The Future Of Oncology Trials

Review the ASCO 2025 Annual Meeting, highlighting oncology trials and the need for agile, globally capable CRO partners to navigate today’s evolving trial landscape.

The Moments That Made Us

Join us as we reflect on our 30-year journey — navigating industry challenges and embracing change, all while driving continuous growth and innovation. 

 

Drug-Drug Interaction (DDI) Studies

Learn how an innovative development platform with the unique ability to fully integrate DDI studies accelerate timelines and improve the likelihood of downstream success.

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Discover how to apply ICH E6 R3 in practice during this expert-led discussion on risk-proportionate approaches in clinical trials. Learn how to integrate and analyze data to streamline oversight, enhance compliance, and improve patient safety. Registration for this Clinical Leader Live digital event is free thanks to the support of Revvity and Medable.

REGULATORY & COMPLIANCE

Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs

The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

Impact Of sIRB Mandates On Study Teams

Explore the practical implications faced by investigators and their support staff, such as navigating new bureaucratic procedures and adhering to revised regulatory requirements.

Explore A Strategic Guide To Running Smarter, Faster Studies

This 2024 Industry Pages report provides an in-depth examination of the Central and Eastern European (CEE) clinical trial strategy, highlighting its pivotal role in global drug development.

Key Updates To Implementing Regulation (EU) 520/2012

The evolving pharmaceutical landscape demands continuous regulatory adaptation to safeguard patient safety and ensure compliance.

Support For Complex Regulatory Documents

The dedicated team of expert writers and editors offer you a wide range of disclosure-related services, including writing, editing, redaction, quality control, and submission.

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