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Biobeat 510(k) for Expanded Wearable Patient Monitor
[135 Words]
[ Price : $8.95]
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| FDA clears a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate. |
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03/29/2022
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Comments on FDA Device Transition Guidance
[2743 Words]
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| Two medical device stakeholders comment on an FDA draft guidance to transition devices into normal compliance when the Covid-19 public health emergency ends. |
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03/29/2022
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FDA Questions ‘Modest’ Benefit in ALS Drug
[497 Words]
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| An FDA advisory committee briefing document released in advance of a 3/30 panel meeting shows the agency is skeptical of the data contained in Amylyx Pharmaceuticals’ NDA for its experimental amyotrophic lateral sclerosis therapy. |
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03/28/2022
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Device Rule Reduces Paper Copy Submissions
[101 Words]
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| Federal Register final rule: FDA amends the medical device regulations to update mailing address information and to reduce the number of copies of certain documents that need to be submitted. |
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03/28/2022
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Animal Drug Regs Amended for Approvals
[89 Words]
[ Price : $8.95]
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| Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during 10/2021, 11/2021 and 12/2021. |
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03/28/2022
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Senator Scott Urges FDA to Fill Vacancies
[482 Words]
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| Senator Rick Scott (R-FL) urges FDA to fill vacant management posts at CDER and CBER because FDA is too important an agency to operate under temporary leadership. |
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03/28/2022
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FDA Budget Request Seeks $2.1 Billion Spending Boost
[1030 Words]
[ Price : $8.95]
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| FDA outlines a $2.1 billion (34%) boost in its fiscal year (FY) 2023 proposed spending plan as part of president Biden’s just-released budget request, which includes $3.7 billion in budget authority – an almost 10% increase of $356 million from the current authorized spending level. |
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03/28/2022
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