Jul. 2 at 7:36 PM
$OMER - "The FDA permits physicians to prescribe approved drugs or devices for off-label uses—meaning for a different condition, age group, or dosage. Because the FDA does not regulate the practice of medicine, they trust a doctor's clinical judgment to treat patients with medications they deem appropriate."
"While physicians have legal freedom to prescribe, the FDA TIGHTLY RESTRICTS how pharmaceutical and medical device companies behave. Companies are LEGALLY PROHIBITED FROM PROMOTING or MARKETING their products for any off-label uses. The agency does not evaluate safety or efficacy for these unapproved uses, and manufacturers cannot make claims about them unless providing specific, peer-reviewed scientific information under strict regulatory guidelines."