Regulatory Affairs Editorial
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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.
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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.
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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.
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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.
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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).
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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.
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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.
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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?
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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.
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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.