Regulatory Affairs Editorial

  1. A Clinical Setback Leads To A Transformation And A New Trial 1/12/2021

    Pharnext is a small pharma company which faced adversity and was able to overcome it. The setback occurred in 2019 when data produced from a Phase 3 trial was rejected by the FDA. That forced the company to make a leadership change and regroup. 

  2. FDA’s Office Of Minority Health And Health Equity Addresses Patient Diversity 12/8/2020

    The diversity of patients participating in clinical trials continues to be a problem in drug development. As sponsors and sites attempt to address the problem, regulators are also doing their best to address the issue. One person deeply involved in this issue is Rear Admiral Richardae Araojo, the associate commissioner for minority health and director of the Office of Minority Health and Health Equity at FDA. 

  3. How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation 8/25/2020

    Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. (Downloadable storyboard template included.)

  4. Unpacking FDA’s New Guidance On Collecting Patient Experience Data 7/28/2020

    The FDA recently released one of what is to be four new guidances providing a general overview of patient-focused drug development. This article summarizes each component of "Guidance 1: Collecting Comprehensive and Representative Input" and details how the guidance may impact sponsors of clinical trials.

  5. Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)? 7/14/2020

    This article will share some thoughts on the current state of regulatory science, by reflecting back on two prominent meetings — the inaugural UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Summit and the Clinical Trials Transformation Initiative (CTTI) Virtual Meetings for Stakeholder Engagement on ICH E6.

  6. How A Small Biotech Survived A Virtual Regulatory Inspection During COVID-19 7/7/2020

    For a small U.S. biotech company, a Japanese Health Authority (MHLW/PMDA) on-site inspection scheduled in March 2020 would be the first of multiple global regulatory pre-approval inspections of its novel product for treatment of a rare disease. Then COVID-19 happened.

  7. How To Prepare For A GCP Inspection During COVID-19 (And Beyond) 3/27/2020

    Facing an upcoming inspection, in many people’s opinion, is perhaps one of the most stressful experiences when working in clinical trials. But how much of this stress is self-inflicted, and what strategies could be deployed to dissipate and better channel the nervous energy released when the inspector comes a-knocking?

  8. Clinical Trials And COVID-19: Don’t Attempt To Do It Alone 3/25/2020

    As the COVID-19 virus continues to wreak havoc across the U.S. and the world, almost no segment of the economy has been spared its impact. That is certainly true of clinical trials conducted by the pharmaceutical industry.

  9. Lilly Slams The Brakes On New Clinical Trial Activity 3/24/2020

    Conducting clinical trials during the COVID-19 pandemic is no easy task. Recognizing this unfortunate change in events caused by COVID-19, Eli Lilly and Company has made the difficult decision to delay most new clinical study starts and pause enrollment in most ongoing studies.

  10. How One Small Biotech Is Changing The Fight Against Cancer 3/17/2020

    Intensity Therapeutics is preparing to kill tumors in a way that has not been attempted before. That effort is also causing challenges with patient recruitment and trial end points.