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Trump Administration Cleaning House at FDA’s Center for Tobacco Products
05 Apr 2025 04:43 GMT
… over vape consumers.
The FDA’s discrimination against the vaping … liquid for e-cigarettes from marketing their products, saying the … of the iceberg on FDA discrimination against vaping products … role in 2022 by former FDA commissioner Robert Califf precisely …
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Congressional Committee Invites Hemp Industry Expert To Testify At Hearing On How FDA ‘Failed’ To Regulate Products
04 Apr 2025 21:52 GMT
… the Food and Drug Administration (FDA), inviting a hemp industry … —titled “Restoring Trust in FDA: Rooting Out Illicit Products”— … take place on Wednesday.
FDA “failed to approve products … about FDA’s refusal to establish rules allowing for the marketing …
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FDA Grants Rare Pediatric Designation to Treatment With NEO100 in Brain Cancer
04 Apr 2025 21:15 GMT
… States Food and Drug Administration (FDA) has granted Rare Pediatric Disease … upon approval of NEO100’s marketing application. The PRV program incentivizes … to working closely with the FDA, as well as any other …
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Orthocell clears FDA regulatory hurdle and is primed to launch into the US with Remplir
04 Apr 2025 03:39 GMT
… the Food and Drug Administration (FDA), giving it the green … to announce we have received FDA clearance for our market- … sales orders.
“Our sales, marketing and education team have made … team of experienced US-based marketing, sales and medical education …
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Level achieved: Orthocell gains FDA approval for flagship nerve repair product
04 Apr 2025 02:10 GMT
… US Food and Drug Administration (FDA) clearance for its flagship … A$2.bn).
Remplir’s FDA approval is a landmark development … medicine companies to have an FDA approval,” Orthocell CEO and … by vice presidents of sales, marketing and medical affairs, supported …
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UPLIZNA® IS NOW THE FIRST AND ONLY FDA-APPROVED TREATMENT FOR IGG4-RELATED DISEASE
03 Apr 2025 23:50 GMT
… Food and Drug Administration (FDA) has approved UPLIZNA as … multiple organs. The FDA granted Breakthrough Therapy Designation … community now has an FDA-approved therapeutic innovation … research, testing, pricing, marketing and other operations are subject …
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Supreme Court upholds FDA’s regulation of e-cigarette flavorings
03 Apr 2025 23:12 GMT
… POINTS: “[W]hen the FDA ultimately denied authorization to respondents … followed through on the [FDA’s 2020 enforcement guidance] warning … … minors.’ Indeed, the FDA’s marketing denial orders stated that respondents … not ‘revers[e the FDA’s] former views as …
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The Supreme Court Blesses the FDA's Rejection of Flavored Nicotine Vapes
03 Apr 2025 21:48 GMT
… agency would require for marketing authorization." A June … to their product. The FDA rejected respondents' applications … FDA changed its mind about the importance of "marketing … telling manufacturers that their marketing plans were 'critical …
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Court Sides with RICO Complainant Who Received Tainted Medical Marijuana and with FDA on Regulating E-Cigarettes - SCOTUS Today
03 Apr 2025 17:57 GMT
… about the FDA’s failure to review marketing plans it … of position on marketing plans. The FDA did not dispute … consider the respondents’ marketing plans. The FDA argued that this was … importance of the FDA’s consideration of marketing a tobacco product …
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U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites
03 Apr 2025 16:53 GMT
… Food and Drug Administration (FDA) has granted Breakthrough Device … results for patients.”
The FDA established the Breakthrough Devices … for premarket approval and marketing authorization.
“We see … later became the first FDA-authorized AI application in …