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Ten pages of warning letters dropped this week, possibly a record. Most came from CDER under the headline: "Unlawful Sale of Unapproved and Misbranded Drugs to U.S. Consumers Over the Internet." 𝗜 𝗱𝗶𝗱𝗻'𝘁 𝗮𝗻𝗮𝗹𝘆𝘇𝗲 𝘁𝗵𝗲𝗺 𝗮𝗹𝗹, 𝗯𝘂𝘁 𝗺𝗼𝘀𝘁 𝗹𝗲𝘁𝘁𝗲𝗿𝘀 𝘀𝗲𝗲𝗺 𝘁𝗼 𝗯𝗲 𝗯𝗮𝘀𝗲𝗱 𝗼𝗻 𝗙𝗗𝗔’𝘀 𝗿𝗲𝘃𝗶𝗲𝘄 𝗼𝗳 𝗰𝗼𝗺𝗽𝗮𝗻𝘆 𝘄𝗲𝗯𝘀𝗶𝘁𝗲𝘀. 𝗧𝗵𝗲 𝗺𝗮𝗶𝗻 𝗽𝗮𝘁𝘁𝗲𝗿𝗻 𝘀𝗲𝗲𝗺𝘀 𝗰𝗹𝗲𝗮𝗿: -Online compounding pharmacies promoting compounded GLP-1

I was asked in another thread about which agency is most concerning (or something to that effect). And it got me thinking. Most regenerative medicine clinics worry about the 𝗙𝗗𝗔......and for good reason. The agency has cracked down on unapproved stem cell, SVF, and amniotic products. But here’s what often gets missed: the 𝗙𝗧𝗖 is just as active, and their lens is very different. 𝙁𝘿𝘼 𝙛𝙤𝙘𝙪𝙨: 𝙥𝙧𝙤𝙙𝙪𝙘𝙩 𝙨𝙖𝙛𝙚𝙩𝙮 & 𝙖𝙥𝙥𝙧𝙤𝙫𝙖𝙡 ▪️Unapproved biologics (e.g

The Hidden Risks Physicians Face With “Stem Cell” Therapies in Florida and Utah Thanks to #𝗰𝗵𝗿𝗶𝘀𝘁𝗼𝗽𝗵𝗲𝗿𝗰𝗲𝗻𝘁𝗲𝗻𝗼  for pushing me to revisit assumptions about physician liability as it relates to states' "stem cell" laws. A deeper look suggests that even with state laws permitting certain stem cell procedures, the risks remain high. Here’s the uncomfortable truth: 𝘀𝘁𝗮𝘁𝗲 𝗽𝗲𝗿𝗺𝗶𝘀𝘀𝗶𝗼𝗻 ≠ 𝗹𝗲𝗴𝗮𝗹 𝗽𝗿𝗼𝘁𝗲𝗰𝘁𝗶𝗼𝗻. Physicians remain exposed on mul

A recent Spine Journal study comparing expandable vs. static TLIF cages caught my attention ( https://pubmed.ncbi.nlm.nih.gov/39349256/...

If you're in the tissue or medical device space, the term   "objective intent"   isn't just regulatory jargon — it's the lens through...

Alex Hormozi's mountain analogy from The Game podcast hit home this week:   "Most of the time, we need perfect conviction about our plan...

After 20+ years in orthopedics, spine, and biologics, I've seen this pattern repeat: companies scramble in Q3/Q4 trying to salvage the...

FDA Shifts from Inspections to Instagram: New Warning Letters Signal Evolving Enforcement Strategy Recent FDA warning letters to two...