Regulatory Affairs Editorial
-
Decentralized Clinical Trials: Embracing The FDA's 2024 Final Guidance
4/16/2025
In Sept. 2024, the FDA unveiled a final guidance aimed at advancing decentralized clinical trials. This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.
-
From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials
4/14/2025
Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.
-
How HHS Budget Cuts And Vaccine Hesitancy Threaten Clinical Trial Operations — And What Leaders Can Do
4/10/2025
Prof. Stacey B. Lee, Ph.D., examines how the recent Department of Health and Human Services (HHS) staffing cuts and vaccine hesitancy combine to make clinical research much more challenging.
-
What Happens If The National Cancer Institute Loses Funding?
4/3/2025
The National Cancer Institute is operating under a continuing resolution that maintains funding at the FY 2024 level of $7.22 billion. But when adjusted for inflation, it effectively reduces the real value of research dollars. So what are the consequences?
-
3 Generative AI Prompts To Strengthen Your SOPs Without Sacrificing Compliance
4/1/2025
Discover three easy and customizable prompts to help support SOP development, refinement, and training — all areas where AI can add immediate value with minimal downside.
-
Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K.
3/26/2025
Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is still rebuilding its regulatory framework post-Brexit.
-
As FDA's "Sex Differences" Guidance Reemerges, UCB Reaffirms Importance Of Including Women In Clinical Research
3/26/2025
UCB Biopharma's Marie Teil explores reasons to prioritize women's inclusion in research and how FDA guidance is poised to support that endeavor.
-
Solving The Protocol Deviation Puzzle With FDA Draft Guidance
3/14/2025
Knowing exactly what to do when a protocol deviation (PD) arises can be challenging. Here, consultant Leila Cupersmith summarizes new FDA guidance on managing PDs.
-
Takeda's Diversity Strategy Pays Off For Phase 3 Trial
3/12/2025
LaShell Robinson, head of global feasibility and trial equity at Takeda explains how the company’s Phase 3 trial for a psoriasis drug ended enrollment well before it’s goal and achieved some impressive diversity metrics.
-
Trends In FDA FY 2024 Inspection-Based Warning Letters
3/7/2025
Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.