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Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
Protandim is a herbal dietary supplement marketed with unsupported claims that it can treat a number of medical conditions. The product is a patented [1] mix of five herbal ingredients and sold by LifeVantage Corporation (formerly LifeLine Therapeutics, Lifeline Nutraceuticals, and Yaak River Resources, Inc), a Utah-based multi-level marketing company. [2]
Mayo v. Prometheus, 566 U.S. 66 (2012), was a case decided by the Supreme Court of the United States that unanimously held that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not patent-eligible subject matter.
In the United States, dietary supplements may be marketed if the manufacturer can show that the supplement is generally recognized as safe, and if the manufacturer does not make any claims about using the supplement to treat or prevent any disease or condition; supplements that contain drugs or advertise health claims are illegal under US law. [20]
The U.S. Food and Drug Administration (FDA) treats melatonin as a dietary supplement and, as such, has not approved it for any medical uses. [17] It was approved for medical use in the European Union in 2007. [8] Besides melatonin, certain synthetic melatonin receptor agonists like ramelteon, tasimelteon, and agomelatine are also used in medicine.
The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Consequently, dietary supplements are defined as a kind of food under the statute, [39] with the caveat that this does not exempt them from being treated as drugs in the way that other foods are exempted, if ...
The BPCI Act was an amendment to the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to a Food and Drug Administration (FDA) approved biological product. [134]
Mayo Clinic is a nonprofit hospital system with campuses in Rochester, Minnesota; Scottsdale and Phoenix, Arizona; and Jacksonville, Florida. [22] [23] Mayo Clinic employs 76,000 people, including more than 7,300 physicians and clinical residents and over 66,000 allied health staff, as of 2022. [5]