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FDA Grants EUA To iHealth's COVID-19 Self-Test Kit

WEBNovember 12, 2021. iHealth Labs has received the FDA’s Emergency Use Authorization (EUA) for over-the-counter sale of its COVID-19 Antigen Rapid Test. iHealth’s current …

Actived: 9 days ago

URL: https://www.fdanews.com/articles/205315-fda-grants-eua-to-ihealths-covid-19-self-test-kit

FDA Launches Next Gen Home Healthcare Device Development …

WEBWith an aim of supporting patients, medical device developers and policymakers, the CDRH has launched a new initiative to deliver virtual reality-enabled …

Category: Medical Go Health

Renewal of Public Health Emergency Means FDA’s Pandemic …

WEBIt’s official: The public health emergency (PHE) that is COVID-19 will continue for at least three more months. The Department of Health and Human Services …

Category: Health Go Health

Federal Judge Tells FDA it Must Make Public 55,000 Pages a

WEBA federal judge in Texas has ruled that the FDA must by the end of this month make public 12,000 pages of the data it used to make decisions about approvals for …

Category: Health Go Health

FDA Seeks Comments on Greater Access to Medical Technologies …

WEBJune 6, 2023. As part of the FDA’s effort to increase access to home-use medical devices, CDRH is seeking comments from devicemakers, researchers, clinicians and the public …

Category: Medical Go Health

Global Medicine Spending and Usage Trends

WEB2 | Global Medicine Spending and Usage Trends: Outlook to 2025 Executive summary The COVID-19 pandemic has been the most impactful global health crisis in decades and …

Category: Medicine Go Health

The US Active Pharmaceutical Ingredient Infrastructure: The

WEBThe US Active Pharmaceutical Ingredient Infrastructure: The current state and considerations to increase US Healthcare Security “Keeping the Nation’s drug …

Category: Health Go Health

CDRH Updates Portal for Tracking Premarket Submissions

WEBCDRH Updates Portal for Tracking Premarket Submissions. March 21, 2023. Devices Regulatory Affairs. As part of its Medical Device User Fee Amendments …

Category: Medical Go Health

REMS as a Tool for Profitability

WEBJames N. Czaban, Esq. Chair, FDA Practice Group Wiley Rein LLP 1776 K Street, N.W. Washington, DC 20006 (202) 719-7411. [email protected]. Presented at ACI’s …

Category: Health Go Health

Managing Medical Device Recalls

WEBRecall Regulatory Framework. 21 C.F.R. Part 7 Subpart C is guidance, not law. Recalls conducted pursuant to Part 7 are “voluntary.”. Defines key terms and provides guidance …

Category: Health Go Health

CDRH Releases Guidances Intended for 2023 2022-10-18

WEBThe Center for Devices and Radiologic Health (CDRH) Monday released a priorities list of draft and final guidance documents it plans to publish in 2023, including …

Category: Health Go Health

Biosimilars in the United States 2020–2024

WEBiqviainstitute.org | 3 • In 2019, the United States spent $493 billion on medicines at ex-manufacturer invoice prices, including $211 billion on biologics, which now comprise …

Category: Medicine Go Health

Big Health’s Sleepio App for Insomnia Gains NICE Recommendation

WEBThe U.K. National Institute for Health and Care Excellence (NICE) is recommending Big Health’s Sleepio software application for treatment for insomnia, for …

Category: Health Go Health

Medical Device Data Systems, Medical Image Storage Devices, …

WEBContains Nonbinding Recommendations. 5 devices pose a low risk to the public. On February 9, 2015, FDA issued a guidance document to inform manufacturers, …

Category: Health Go Health

FDA Clears Alydia Health’s Postpartum-Bleeding Device

WEBThe FDA has given Alydia Health 510(k) clearance for its Jada system, a device that controls and treats postpartum hemorrhage (PPH) and abnormal postpartum uterine …

Category: Health Go Health

NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol

WEBNIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template . NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017 c • Guideline for Industry, E3 …

Category: Health Go Health

other Tools) Resource BEST (Biomarkers, EndpointS, and

WEBBEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Co-published by National …

Category: Food Go Health

Patient-Focused Drug Development: Methods to Identify …

WEB94 Qualitative research methods (e.g., through interviews or focus groups), quantitative research. 95 methods (e.g., through survey instruments), or mixed-methods …

Category: Health Go Health

Food and Drug Administration Strategic Priorities 2014-2018

WEBGoal 4: Strengthen Organizational Excellence and Accountability. These strategic priorities as well as core mission goals and objectives provide an integrated framework for …

Category: Health Go Health