Regulatory Affairs Editorial

51. The Small Biotech's Checklist For FIH Trials 8/27/2024

    Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

52. FDA Under Pressure To Respond To China-Related Clinical Trials Questions 8/27/2024

    The FDA has until October 1, 2024 to respond to a number of questions regarding concerns about clinical trials being conducted in The People's Republic of China. How will their answers affect trials going forward and the sponsors that were conducting those China-based trials?

53. Summing Up The FDA's Long-Anticipated Draft Guidance On Diversity Action Plans 8/26/2024

    Life sciences attorney Marylana Saadeh Helou summarizes the FDA's draft guidance on Diversity Action Plans (DAPs).

54. Individual Participant Data Return Solutions And Strategies 8/22/2024

    Paula Boyles, external clinical trial data-sharing program lead for Pfizer and TransCelerate BioPharma member, shares the benefits of and strategies for individual patient data return (iPDR).

55. Operationalizing A Diversity Action Plan That Makes An Impact 8/19/2024

    In part two of this series on creating a diversity action plan (DAP), Elevate Advocacy's Devra Densmore shares a detailed plan for creating a DAP that meets FDA expectations.

56. Diversity Action Plan (DAP): Creating An Ecosystem For Success 8/12/2024

    In part one of this two-part series, Elevate Advocacy Founder Devra Densmore explores how to create an ecosystem in which a successful diversity action plan (DAP) can be written and executed.

57. FDA Talks Help Cybin Advance Two Psychedelic Drugs Toward Approval 7/26/2024

    Cybin CEO Doug Drysdale discusses regulatory considerations relating to the pursuit of two different psychedelic drugs and talks about trends in the larger psychedelic drug space.

58. Easy Mistakes To Make During An FDA Inspection 7/25/2024

    As a former FDA investigator, Vincent Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator.

59. How Early Talks With The FDA Can Pave Your DTx Approval Pathway 7/22/2024

    Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.

60. Extended GCP Training Is A "Must" For Cell And Gene Therapy Clinical Trials 7/18/2024

    Cell and gene therapies (CGTs) carry specific challenges and risks, and so all parties need enhanced training to ensure patient safety, data quality, and Good Clinical Practice (GCP) and regulatory compliance.