FDA guidance

Let’s say there’s a Black female patient with an aggressive form of breast cancer. She meets with her oncologist to discuss a promising targeted therapy that recently won FDA approval. The drug showed strong efficacy in clinical trials, with a 65% response rate. Yet when she asks about efficacy data specific to Black women, she…

The U.S. Food and Drug Administration (FDA) recently released a draft guidance titled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” This 40-page document, while not legally binding, offers insights into best practices for common questions received by the Office of Therapeutic Products (OTP). While each question is answered in brief, the…

Abstract Despite a wealth of case studies and recent FDA guidance highlighting the advantages of community-level engagement in clinical trials, local clinics and research sites with access, trust, and experience in treating diverse patient populations are frequently overlooked and under-resourced in the drug development process. Lloryn Hubbard and Zoé Felicié, patient diversity experts at the PPD Clinical…

While diversity in clinical trials has won attention in recent years, uneven representation of diverse populations in clinical trials remains a core barrier to global healthcare equity. Real-world data (RWD) paired with artificial intelligence techniques can almost instantly analyze how well drugs work in diverse subpopulations once they hit the market. RWD can also help…

In a sign of shifting attitudes, the FDA has released draft guidance to facilitate the development of psychedelic drugs. Historically, psychedelics have a long history of use in certain cultures, such as the indigenous tribes of the Amazon Basin and Native American communities, for millennia as sacraments.These substances were used not only recreationally but also…