GUEST COLUMNISTS

• Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs

  The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

• How Is RIM Software Transforming Regulatory Compliance?

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

• Why CRA Proficiency Needs A Boost From Better Assessment And Training

  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.

• EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?

  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

• Single Peptides & Pig Testing: How Longhorn's Developing Its Universal Flu Shot

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

• BioMarin Generates Patient Experience Data With Early And Often Engagement

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

• 5 Ways To Make Your Investigator Meetings Fun And Functional

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

• 2 Ways To Overcome The Challenge Of Developing Neurological Rare Diseases Drugs

  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.