Regulatory Affairs Editorial

  1. Top 10 Considerations For U.S. Biotechs Setting Up Clinical Studies In Europe 7/5/2024

    Chris Moore, clinical project manager at Boyds, provides 10 key considerations for U.S. biotechs and small pharma companies on navigating the new EU Clinical Trials Regulation (CTR).

  2. What's Lacking In FDA's Latest Diversity Guidance? 6/27/2024

    The FDA’s new guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies includes several changes from the previous guidance, but there are a few key areas where this new guidance falls short.

  3. Cell Therapies For Solid Tumors: Optimizing Your Approach To Achieve Regulatory Approval 6/19/2024

    Developing and ultimately obtaining approval of cell therapies for solid tumors requires an organized and scientifically rigorous approach. This article is a helpful road map of considerations.

  4. Psychedelic Community Reacts To FDA Committee's Critique Of Lykos' MDMA Studies 6/14/2024

    An FDA advisory committee rejected the validity of therapy-assisted MDMA clinical trials conducted for the treatment of PTSD. What does the committee’s vote mean for the pursuit of MDMA and other psychedelic therapies?

  5. A Couple's Plan To Revamp Poland's Clinical Trial System 6/11/2024

    Hanna and Artur Preus collected and analyzed 3,208 questionnaires from patients, pharma companies, CROs, site staff, and private companies to identify the shortcomings in the Polish clinical trials system and then make recommendations on how to improve it.

  6. Is Your Intellectual Property Safe With Indian CROs And CDMOs? 6/3/2024

    Startups and Big Pharma companies alike are considering India as an alternative to working with China. Is it safe to do business with India? Let's do a deep dive, with insights from American and Indian attorneys.

  7. How IRBs Can Keep Up With the Rest Of The Clinical Research Industry 5/29/2024

    Univo IRB CEO Julie Blasingim explores the new era of IRBs and how they can leverage technology to stay on pace with and meet the needs of the rest of the clinical research industry.

  8. FDA Issues New Draft Guidances On Cancer Clinical Trial Eligibility Criteria 5/28/2024

    Understand the latest FDA guidance on cancer clinical trials with summary and content from Marjorie Zettler, Ph.D., MPH.

  9. Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies 5/24/2024

    The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.

  10. Clinical Investigation Plans: The Role Of MDCG 2024-3 In The Context Of EU MDR Annex XV, ISO 14155 5/22/2024

    The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How does it complement existing guidance and regulation?