Laudanum of opium tincture prevails today only because opium tincture was sold prior to the Federal Food, Drug & Cosmetic Act of 1938. Its "grandfathered" status protects opium tincture from being required to undergo strict FDA drug reviews and subsequent approval processes. However, the FDA closely monitors the labeling of opium tincture. Bottles of opium tincture are required by the FDA to bear a bright red "POISON" label given the potency of the drug and the potential for overdose (see discussion about confusion with Paregoric below). Despite opium tincture being an "unapproved drug" as discussed above, a search of FDA's website
Personalized medicine of personalised medicine to further fields of medicine, which requires the interdisciplinary cooperation of experts from specific fields of research, such as medicine, clinical oncology, biology, and artificial intelligence. The FDA has already started to take initiatives to integrate personalised medicine into their regulatory policies. An FDA report in October 2013 entitled, “"Paving the Way for Personalized Medicine: FDA’s role in a New Era of Medical Product Development",” in which they outlined steps they would have to take to integrate genetic and biomarker information for clinical use and drug development. They determined that they would have to develop specific regulatory