FDA Law Blog

OCTOBER 14, 2024

By Steven J. Gonzalez — On September 27, 2024, in U.S. v. California Stem Cell Treatment Center, Inc., a Ninth Circuit panel unanimously held that a stem cell clinic’s Stromal Vascular Fraction (SVF) procedure constitutes a “drug” under the Food, Drug and Cosmetic Act (FDCA) and does not meet the “same surgical procedure” (SSP) exception to FDA’s regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) contained in 21 C.F.R.

Clinic 59

Clinic Patient-Centered Asthma Patients 59

PEMBlog

OCTOBER 14, 2024

Did you know that pancreatitis is mostly caused by viruses in kids? They don’t drink alcohol or get gallstones like grown ups. Also, scorpion bites apparently cause it. But that’s silly and only something you see in board review books. Anyway, this would be a better Broadway musical than most retreads of 1980s & 90s movies. Lyrics [Verse] Pancreatitis calls out my name The pain the intensity, I cannot explain My mom said I ate too many wings My dad told me to focus on more pleasa

Medical 52

Medical Utilities IT 52