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The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s at Survival Technology in Bethesda, Maryland, US by Sheldon Kaplan [11] [12] and was first approved for marketing by the FDA in 1987. [13] One of the people who helped in making the EpiPen was Richard B. Toren.
Now, the Food and Drug Administration (FDA) has approved a new option for patients with severe allergies—and it doesn’t involve needles. It’s called Neffy, and it’s already getting plenty ...
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The data are stored electronically by the CDC in the Vaccine Safety Datalink (VSD). VAERS was established in 1990 and is managed jointly by the FDA and the CDC. [5] It is meant to act as a sort of "early warning system" [6] —a way for physicians and researchers to identify possible unforeseen reactions or side effects of vaccination for ...
Those profits were also due in part to Mylan's continually raising the price of EpiPens starting in 2009; in 2009 the wholesale price of two EpiPens was about $100, by July 2013 the price was about $265, in May 2015 it was around $461, and in May 2016 the price rose again to around $609, [90] around a 500% jump from the price in 2009. [94]
EpiPen autoinjectors allow the patient or a caretaker to administer a dose of epinephrine in case of a severe allergic reaction, such as to bee stings or exposure to peanuts.
The FDA has a "priority review process" for drugs which compete with another drug whose price exceeds its value-based price. Congress could also grant the FDA the ability to change the exclusivity period for new drugs. [6] The FDA could also temporarily allow the import of drugs approved for sale outside the United States. [69]
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