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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:
Allergen of the Year is an annual "award" voted upon by the American Contact Dermatitis Society, aiming to raise awareness about common allergens. The purpose of the award is "to draw attention to the agents causing the most significant clinical effects, those that are underrecognized and those that have become obsolete or for which exposure patterns have changed".
In 1996, the FDA approved the switch of Nicorette gum and the NicoDerm CQ transdermal nicotine patch to over-the-counter status in the US. [36] The Nicorette inhaler was launched in 1996 [35] and Nicorette Microtab (sublingual tablets) in 1999. [37] In 2002, the FDA changed the status of Commit lozenges to over the counter in the US. [36]
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David J. Graham is an American epidemiologist who is the Associate Director of the Food and Drug Administration's Office of Drug Safety. Graham has spent his career at the FDA studying the safety of drugs, many of them after approval using data from medical insurance companies.
The following is a list of WHO recommended strains for the Northern Hemisphere influenza season. Starting in the 2012–2013 season, the recommendation shifted to include the composition of a quadrivalent influenza vaccine (QIV) that contains both influenza B lineages, alongside a trivalent influenza vaccine (TIV) containing one influenza B lineage.
The US Food and Drug Administration has proposed setting lead levels in baby food of 10 parts per billion for many products and 20 parts per billion for cereals and root vegetables, which can ...
Valdecoxib was manufactured and marketed under the brand name Bextra by G. D. Searle & Company as an anti-inflammatory arthritis drug. [3] It was approved by the United States Food and Drug Administration (FDA) on November 20, 2001, to treat arthritis and menstrual cramps, [ 4 ] [ 5 ] and was available by prescription in tablet form until 2005 ...