Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres

Bill of Health

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust , oncologist Mikkael A. Sekeres centers his narrative on the controversial 2011 Avastin hearings , in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug.

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Pig Hearts for Humans and the FDA

Bill of Health

Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. In 2016, the FDA updated previously existing guidance for xenotransplantation. Xenotransplantation Products at the FDA. By Jacob Balamut.

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Tobacco Issues Awaiting Robert Califf at the FDA

Bill of Health

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. By Cathy Zhang.

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FDA issues first EUA for monkeypox test

Healthcare Dive

Quest Diagnostics' PCR test for monkeypox received emergency use authorization after the FDA issued guidance on how it will evaluate the tests

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Dexcom Receives FDA Clearance for G7 Continuous Glucose Monitoring (CGM) System

HIT Consultant

What You Should Know: – The FDA has cleared Dexcom G7 continuous glucose monitoring (CGM) system in the U.S. Digital Health Health IT apple Apple Watch Dexcom diabetes Diabetes Management digital health Digital Health Apps FDA FDA Clearance insulin Wearables

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FDA’s Cybersecurity Modernization Action Plan

HealthIT Answers

The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility. The post FDA’s Cybersecurity Modernization Action Plan appeared first on Health IT Answers.

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Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market

Bill of Health

Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use. How should the FDA regulate recreational drugs, if it has the power to do so? The FDA’s Existing Authority.

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FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Healthcare Dive

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision

Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

Bill of Health

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. By Matthew Chun.

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Aetion, FDA to Evaluate Real-World Data Standardization for COVID-19

HIT Consultant

What You Should Know: – Aetion , a provider of real-world evidence (RWE) technology and analytics, today announced that the FDA has extended Aetion’s contract to evaluate real-world data (RWD) involving COVID-19 medical countermeasures.

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

First, let’s examine the new regulatory framework the FDA established. By allowing retail sales of affordable hearing aids, the FDA regulations go a long way in helping consumers address this challenge yet could result in risk to health plans.

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Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App

HIT Consultant

What You Should Know: – Arterys , the world’s leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI clinical application and an additional FDA AI clearance based on deep learning.

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Medical Devices Cleared or Approved by FDA in 2022

HIT Consultant

In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. Here’s a breakdown of some of the most anticipated otc medical devices that have already received FDA approval. Some of these new FDA medical devices will truly impress you.

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FDA warns about unauthorized versions of rapid COVID-19 tests from 3 manufacturers

Healthcare Dive

But the FDA has learned some unauthorized versions of their diagnostics have entered the country The manufacturers have all received emergency use authorizations for antigen tests.

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FDA digital health chief talks new role with agency, AI tech

Healthcare Dive

Bakul Patel, the Center for Devices and Radiological Health's chief digital health officer, will help FDA meet its 2022-2025 strategic priorities and set regulatory policies for the new technologies such as AI and machine learning

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Biotricity Awarded FDA 510(k) Clearance for Cardiac Monitoring Device

HIT Consultant

Food and Drug Administration (FDA) for its Biotres Cardiac Monitoring Device, a three-lead device for ECG and arrhythmia monitoring that is intended for lower-risk patients. Digital Health biotricity Cardiac Monitoring FDA FDA clearance 510k

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Cardiologs Awarded FDA Clearance for Pediatric Use of Algorithm

HIT Consultant

What You Should Know: Cardiologs announced today that the FDA has cleared their algorithm to be used for the pediatric population – younger than 18. Food and Drug Administration (FDA) to use its AI-powered cardiac diagnostics platform for pediatric cardiology.

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RapidAI Awarded FDA Clearance for AI-Powered CT Scans to Identify Intracerebral Hemorrhage

HIT Consultant

What You Should Know: – RapidAI , the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity , the newest addition to the RapidAI platform.

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FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

HIT Consultant

What You Should Know: – Today, Eko , a digital health company advancing heart and lung disease detection, has announced the FDA has issued clearance for its Eko Murmur Analysis Software (EMAS), the first and only machine learning algorithm to screen for valvular heart disease (VHD).

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FDA takes N95 respirators off medical device shortage list

Healthcare Dive

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said

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FDA Awards 510(k) Clearances for ZEUS System/Zio Watch

HIT Consultant

What You Should Know: – Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System and Zio Watch.

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FDA Further Harmonizing Clinical Research Regulations with HHS Common Rule

HealthIT Answers

The post FDA Further Harmonizing Clinical Research Regulations with HHS Common Rule appeared first on Health IT Answers. Regulatory Issues Ann Meeker-O’Connell MS clinical trials FDA Voices HHS Hilary Marston MD MPH

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5 takeaways from the FDA’s list of AI-enabled medical devices

Healthcare Dive

As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates

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FDA clarifies cybersecurity recommendations for device makers in new guidance

Healthcare Dive

The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions

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Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids

Healthcare Dive

The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5

Avenda Health Receives FDA Exemption for AI-Enabled Prostate Cancer Therapy

HIT Consultant

What You Should Know: – Avenda Health , an AI healthcare company creating the future of prostate cancer care, has received FDA Investigational Device Exemption (IDE) for its FocalPoint ablation system. Digital Health Life Sciences AI Artificial Intelligence cancer FDA physicians

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FDA clears Novavax's COVID-19 vaccine as 4th option in US

Healthcare Dive

The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron

Apple Watch monitoring features for AFib, Parkinson's cleared by FDA

Healthcare Dive

With the new feature, atrial fibrillation patients may have an easier way to track the frequency of the condition over time and see whether lifestyle changes may have positive effects

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FDA warns of cyber vulnerabilities in medical device software components

Healthcare Dive

An agency alert warned that flaws in PTC's Axeda agent and desktop server, used in devices from several manufacturers, could allow an unauthorized attacker to take full control of the host operating system

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Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib

HIT Consultant

What You Should Know: – Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 Digital Health Atrial Fibrillation FDA FDA Clearance Fitbit Heart risk

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The FDA Ramps Up GMP Inspections

Dot Compliance

Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments.

5 FDA decisions to watch in the second quarter

Healthcare Dive

Between April and June, the agency will advance key regulatory reviews in ALS and gene therapy as well as host an advisory meeting on cancer drugs

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Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules

Healthcare Dive

The HHS Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed

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FDA must improve medical device interoperability through data standards: JAMA

Healthcare Dive

The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case

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FDA Releases Updated Guidance on Medical Device Cybersecurity

HIPAA Journal

Food and Drug Administration (FDA) has issued new draft guidance for medical device manufacturers to help them incorporate cybersecurity protections into their products at the premarket stage, and to ensure security risks are managed for the full life cycle of the products. The U.S.

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AdvaMed asks FDA to withdraw divisive draft guidance on LASIK surgery

Healthcare Dive

Some comments were more positive, though, with the American Optometric Association calling the agency’s proposal “timely and beneficial &rdquo

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RapidAI Receives FDA 510(k) Clearance for Pulmonary Embolism Triage & Notification

HIT Consultant

Digital Health AI Artificial Intelligence care teams Clinical Decision Support decision support FDA Patient Care physicians

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FDA releases medical device cybersecurity draft guidance

Healthcare IT News - Telehealth

"These recommendations can facilitate an efficient premarket review process and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats," said FDA in the Federal Register notice about the guidance. The U.S.

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'Where's the patient?': Experts question FDA's final recall guidance

Healthcare Dive

While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system

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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Collectively, these guidances cover a range of digital health issues, and it is worth reading FDA Commissioner Scott Gottlieb’s statement about them as well as each individual document: Clinical and Patient Decision Support Software (CDS and PDS) (Draft). Comments Digital health figures in FDA's 2018 strategic roadmap.

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Medical Device Cybersecurity Requirements Stripped from FDA Reauthorization Bill

HIPAA Journal

Were the FDA’s 5-year authorization not to be renewed, the FDA anticipated only being able to continue with its review activities for around 5 weeks before its money ran out. The U.S

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FDA clears updated COVID-19 boosters from Pfizer, Moderna

Healthcare Dive

The new shots, which are designed to better target circulating strains of omicron, could be available within days. Advisers to the CDC are set to meet later this week

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FDA releases draft guidance for Breakthrough Devices Program aimed at health inequities

Mobi Health News

When determining approval for Breakthrough Device designation, the FDA will consider whether the device addresses present health inequities

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