Clinical Guest Contributors

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 Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs 6/20/2025

    The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 5 Ways To Make Your Investigator Meetings Fun And Functional 6/17/2025

    Discover five ways CROs and sponsors can better engage and communicate with site staff for better relationships and better trials.

  8. 2 Ways To Overcome The Challenge Of Developing Neurological Rare Diseases Drugs 6/16/2025

    GRIN Therapeutics CEO Bruce Leuchter, MD, explores how integrating new business models and technological advances will be crucial to developing new treatments for rare neurological disorders.

  9. Hidden Compliance Risks In Start-Up That Could Derail Your Clinical Trial 6/13/2025

    Kulkarni Law Firm Senior Attorney Edye T. Edens explores the risks embedded in clinical trial start-up activities, such as site activation, contract execution, delegation of responsibilities, and cross-border data flows.

  10. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.