Regulatory Affairs Editorial

  1. FDA's CBER Issues Final Guidance For CAR T Cell Products 2/15/2024

    The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.

  2. Trends In FDA FY2023 Inspection-Based Warning Letters 2/13/2024

    The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.

  3. Strategies For Seeking Multiregional Regulatory Approval 2/12/2024

    Consultant Peter Embley discusses the importance of developing a regulatory strategy (RS) that intends to support both U.S. and EU regulatory approval.

  4. FDA Guidance On Standardizing Diversity And Inclusion Terminology And Collection 2/9/2024

    Last week, the FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.

  5. FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products” 1/26/2024

    Accenture Applied Life Science Solutions' Raj Bandaru, Ph.D. breaks down, summarizes, and shares detailed insight on the recent FDA Draft Guidance that addresses “Rare Diseases: Considerations for the Development of Drugs and Biological Products.”

  6. Understanding FDA's Rare Disease Therapeutics Pilot Program 12/18/2023

    FDA aims to advance medical research and therapeutic solutions for rare diseases with its Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program. 

  7. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

  8. Trip Or No Trip: Pharmas Are Taking Psychedelic Trials To Australia 12/13/2023

    Enveric Biosciences CEO Joseph Tucker, Ph.D., chronicles the company's quest for regulatory approval in Australia, as well as navigates the unknowns of developing psychedelics for therapeutic use.

  9. Who Are Your TMF Customers? The Key To Greater Trial Efficiency & Quality 12/12/2023

    Could your director of clinical operations or TMF manager identify all customers of the TMF? Perhaps not. Learn why knowing all customers is so important to efficient, high-quality trials.

  10. Are Your Trials Compliant With The Updated Physician Payments Sunshine Act? 12/7/2023

    Sponsors must proactively mitigate Sunshine Act compliance risks by conducting thorough internal audits, reevaluating policies and procedures, and ensuring all financial interactions with healthcare providers align with legal and ethical standards.