Industry Insights

31. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

    Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

32. Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs 6/20/2025

    The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

33. How Is RIM Software Transforming Regulatory Compliance? 6/20/2025

    Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

34. Why CRA Proficiency Needs A Boost From Better Assessment And Training 6/20/2025

    CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.

35. New Data Sources Can Help Pharma Meet Challenges 6/19/2025

    Claire Riches, Citeline VP of Clinical Solutions, discussed the changing pharma landscape and data options, such as RWD, RWE, and AI at Citeline Elevate Spring 2025.

36. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

    The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

37. Single Peptides & Pig Testing: How Longhorn's Developing Its Universal Flu Shot 6/19/2025

    CEO Jeff Fischer discusses Longhorn's long-acting universal flu vaccine, from its suitability for testing in pigs to overcoming vaccine hesitancy.

38. Key Updates To Implementing Regulation (EU) 520/2012 6/18/2025

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

39. Top 9 AI Implementation Strategies For Pharmacovigilance 6/18/2025

    By following these nine strategies, organizations can implement AI in pharmacovigilance responsibly, ensuring systems that are aligned with the goal of improving patient safety and public health outcomes.

40. BioMarin Generates Patient Experience Data With Early And Often Engagement 6/18/2025

    BioMarin Pharmaceutical's Ebony Dashiell-Aje, Ph.D., discusses how early and often patient engagement facilitates rich patient experience data generation.