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User Fee Legislation Markup Suggests Added FDA Regulatory Authorities

User Fee Legislation Markup Suggests Added FDA Regulatory Authorities

May 17, 2022 – Considering that the Food and Drug Administration (FDA) receives nearly half of its funding from medical product user fees, the timely reauthorization of user fees before the current iteration expires Sept. 30 is paramount to ensuring smooth product review operations. But this “must-pass” legislation opens the door to additional priorities and […]

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Legislative

Congress Should Make Lowering Drug Prices a Top Priority, POLITICO-Harvard Poll Says

Congress Should Make Lowering Drug Prices a Top Priority, POLITICO-Harvard Poll Says

Oct. 2, 2017 – According to a recent poll conducted by POLITICO and Harvard T.H. Chan School of Public Health, 40 percent of those surveyed said that lowering prescription drug prices should be Congress’ number one priority for the remainder of 2017. Just 26 percent of the public stated that repealing and replacing Obamacare should […]

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ACA ad tax CDER chc CMS coalition for healthcare communication conflict of interest Congress COVID-19 data privacy data privacy legislation DDMAC drug prices in DTC ads drug pricing DTC DTC advertising DTC advertising FDA FDA Commissioner FDA Draft Guidance FDA enforcement FDA social media FTC HHS Jim Potter John Kamp Jon Bigelow kamp Kate Rawson legislation litigation off-label off-label communication OPDP OPDP enforcement PhRMA privacy regulation rx data Scott Gottlieb social media sunshine act Untitled Letter Warning Letter Wayne Pines