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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 ...
In 1996, the FDA issued the "FDA Rule," which asserted its authority over tobacco products and issued a rule intending to prevent and reduce tobacco use by children. The intended regulations included prohibiting non-face-to-face sales of tobacco products, prohibiting outdoor advertising of tobacco products near schools or playgrounds, imposing ...
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to ...
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FDA-approved drugs for indications that are supported (as opposed to listed) in the compendia." Medicaid State Rebate Release No. 141 (May 4, 2006) (emphasis added). Thus, even if a drug is FDA-approved for one indication, Medicaid ordinarily does not cover other uses that do not qualify as medically accepted indications. The TRICARE Program 22.
Give employees time to acclimate. OSHA recommends the so-called “20% rule.” “On the first day, don’t allow employees to work more than 20% of a shift at full intensity in the heat ...
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