Regulatory Affairs Editorial

  1. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

  2. What To Expect From An FDA Inspection 4/26/2024

    Former FDA inspector turned regulatory consultant, Patrick Stone, gives some valuable insights to what to expect when the FDA comes knocking at your clinical trial site. Here's a hint: make sure you PI knows the difference between presiding over and overseeing a study.

  3. Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024 4/17/2024

    This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.

  4. FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions 4/11/2024

    The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.

  5. ICH E6(R3) And Defining What Is Critical To TMF Quality 4/9/2024

    By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).

  6. AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance 4/8/2024

    The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

  7. New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials 4/1/2024

    In a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials. The public comment period ends April 15, 2024.

  8. FDA, MHRA, Health Canada Joint GCP Symposium Focuses On 3 Key Topics 3/27/2024

    The FDA, the U.K. MHRA, and Health Canada recently came together for a symposium on GCP with focus on the ICH E6 harmonized guideline and two other key topics.

  9. Why Jane Myles Believes DCTs Are "Completely Doable" 3/27/2024

    If you want to know about how perceptions regarding DCTs are changing, talk with Jane Myles of the DTRA (Decentralized Trials & Research Alliance). As Program Director at DTRA, she is acutely aware of all the challenges and opportunities surrounding anything with the term “decentralized trial.”

  10. Reducing The Number Of Clinical Holds On Cell And Gene Therapies: Approaches For Sponsors And The FDA 3/25/2024

    There is a large proportion of clinical trials for cell and gene therapies that the FDA places on clinical hold. Why is this, and what can sponsor companies and the FDA do differently?