First looks and fast takes on LDT final rule The Food and Drug Administration’s final rule on laboratory-developed tests was released April 29 and published May 6. Shortly after, The Compass Group Laboratory Leaders leaders met online with CAP TODAY publisher Bob McGonnagle, who asked for their early reactions to what they heard and read. https://lnkd.in/gZCwUdQt
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Stakeholders should have input.
Industry groups are pouring cold water on the US Food and Drug Administration’s suggestion that it might issue more guidance documents for immediate implementation, before stakeholders can provide comments. Mary Ellen Schneider reports in Regulatory Focus 📝 📣 https://bit.ly/3v4nU66
Industry advises FDA not to issue more guidances without public comment
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I have more than two decades experience helping pharmaceutical, medical device, biologics and life science clients comply with US drug, biological and medical device law.
FDA should not be issuing guidances without public comments. Industry comments are necessary to make guidances practical enough to implement. Drafting guidances without practical and economic input is unfair to industry. #FDA #publiccomments #practicalguidances
Industry groups are pouring cold water on the US Food and Drug Administration’s suggestion that it might issue more guidance documents for immediate implementation, before stakeholders can provide comments. Mary Ellen Schneider reports in Regulatory Focus 📝 📣 https://bit.ly/3v4nU66
Industry advises FDA not to issue more guidances without public comment
raps.org
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Stay ahead with the Food and Drug Administration's FY2024 priorities overview. Part 1 of our alert series is out. Get insights into regulatory shifts and developments: https://ow.ly/E8Kj50Qvsrk
An Overview of the US Food and Drug Administration's Legislative Goals (Part I)
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FDA Announces Open Registration for Fifth Online Controlled Substances Summit On July 25-26, 2024, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA, will host FDA’s fifth “Online Controlled Substances Summit,” a two-day virtual public meeting that will focus on identifying innovative solutions to reduce the illegal availability of controlled substances online. The illegal sale of controlled substances over the internet poses significant health risks to consumers of all ages. We are deeply concerned about the continued availability of controlled substances, such as opioids, benzodiazepines and stimulants—through social media, websites and other online platforms. This availability increases our public health concerns due to the heightened risks associated with the combined use of these products. https://lnkd.in/gRXV9zHS
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We are delighted to announce the launch of Scientific Update 18 with the focus on science-based regulation. Browse through it here ➡️ https://lnkd.in/egB5KFGj Did you know that various countries regulate novel smoke-free products under unique or dedicated product categories, recognizing that not all tobacco products are equally harmful? We dedicated an article explaining the complex landscape of regulations on smoke-free products across the world. The absence of combustion generally equates to the absence of smoke. This widely known fact is still being debated. We dig deeper and explain why the aerosol from our Tobacco Heating System is not smoke. Finally, we highlight some of the challenges in the U.S. regulatory landscape, one of them being the unpredictability in the time it takes the U.S. Food and Drug Administration to review premarket product applications. #ScientificUpdate #RegulatoryFramework #USregulation #Policy
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Working in global recruitment marketing to attract the best talent to join our employee centric, inclusive organisation
We are delighted to announce the launch of Scientific Update 18 with the focus on science-based regulation. Browse through it here ➡️ https://lnkd.in/dDK9sfrP Did you know that various countries regulate novel smoke-free products under unique or dedicated product categories, recognizing that not all tobacco products are equally harmful? We dedicated an article explaining the complex landscape of regulations on smoke-free products across the world. The absence of combustion generally equates to the absence of smoke. This widely known fact is still being debated. We dig deeper and explain why the aerosol from our Tobacco Heating System is not smoke. Finally, we highlight some of the challenges in the U.S. regulatory landscape, one of them being the unpredictability in the time it takes the U.S. Food and Drug Administration to review premarket product applications. #ScientificUpdate #RegulatoryFramework #USregulation #Policy
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We are delighted to announce the launch of Scientific Update 18 with the focus on science-based regulation. Browse through it here ➡️ https://lnkd.in/eeVWM_7c Did you know that various countries regulate novel smoke-free products under unique or dedicated product categories, recognizing that not all tobacco products are equally harmful? We dedicated an article explaining the complex landscape of regulations on smoke-free products across the world. The absence of combustion generally equates to the absence of smoke. This widely known fact is still being debated. We dig deeper and explain why the aerosol from our Tobacco Heating System is not smoke. Finally, we highlight some of the challenges in the U.S. regulatory landscape, one of them being the unpredictability in the time it takes the U.S. Food and Drug Administration to review premarket product applications. #ScientificUpdate #RegulatoryFramework #USregulation #Policy
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We are delighted to announce the launch of Scientific Update 18 with the focus on science-based regulation. Browse through it here ➡️ https://lnkd.in/dRVUQCi9 Did you know that various countries regulate novel smoke-free products under unique or dedicated product categories, recognizing that not all tobacco products are equally harmful? We dedicated an article explaining the complex landscape of regulations on smoke-free products across the world. The absence of combustion generally equates to the absence of smoke. This widely known fact is still being debated. We dig deeper and explain why the aerosol from our Tobacco Heating System is not smoke. Finally, we highlight some of the challenges in the U.S. regulatory landscape, one of them being the unpredictability in the time it takes the U.S. Food and Drug Administration to review premarket product applications. #ScientificUpdate #RegulatoryFramework #USregulation #Policy
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We are delighted to announce the launch of Scientific Update 18 with the focus on science-based regulation. Browse through it here ➡️ https://lnkd.in/eEYv3ReW Did you know that various countries regulate novel smoke-free products under unique or dedicated product categories, recognizing that not all tobacco products are equally harmful? We dedicated an article explaining the complex landscape of regulations on smoke-free products across the world. The absence of combustion generally equates to the absence of smoke. This widely known fact is still being debated. We dig deeper and explain why the aerosol from our Tobacco Heating System is not smoke. Finally, we highlight some of the challenges in the U.S. regulatory landscape, one of them being the unpredictability in the time it takes the U.S. Food and Drug Administration to review premarket product applications. #ScientificUpdate #RegulatoryFramework #USregulation #Policy
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Truth beats Storytelling // AI for communications geek // Philosophy of Technology and Science // Philip Morris International
We are delighted to announce the launch of Scientific Update 18 with the focus on science-based regulation. Browse through it here ➡️ https://lnkd.in/dDTGyjP6 Did you know that various countries regulate novel smoke-free products under unique or dedicated product categories, recognizing that not all tobacco products are equally harmful? We dedicated an article explaining the complex landscape of regulations on smoke-free products across the world. The absence of combustion generally equates to the absence of smoke. This widely known fact is still being debated. We dig deeper and explain why the aerosol from our Tobacco Heating System is not smoke. Finally, we highlight some of the challenges in the U.S. regulatory landscape, one of them being the unpredictability in the time it takes the U.S. Food and Drug Administration to review premarket product applications. #ScientificUpdate #RegulatoryFramework #USregulation #Policy
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