Health Law Advisor

APRIL 4, 2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. But with the static presentation, I thought I would graph it in a bar chart.

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Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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FDA Informed Consent COVID-19 Fraud 40

Bill of Health

MARCH 4, 2024

But the most pertinent lobbying is currently working to shape the FDA’s guidelines for psychedelic therapy. FDA Psychedelic Draft Guidance When administrative agencies propose new guidelines or rule changes, companies, trade groups, academics, and engaged citizens reply with specific concerns.

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FDA Governance 135

Mobi Health News

APRIL 3, 2019

An exploratory whitepaper dropped yesterday lays out a framework that the FDA hopes to present in a future draft guidance.

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Health Law Advisor

MARCH 3, 2023

Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives. [1] However, FDA found that consumers do not appear to understand the nutritional differences between plant-based milk and cow-derived milk. On February 22, 2023, the U.S.

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FDA Governance 52

Hall Render

SEPTEMBER 15, 2023

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to be 5-HT2 agonists (e.g.,

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FDA Licensing Compliance 40

Health Law Advisor

MARCH 1, 2023

To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests. FDA has been releasing data on its FOIA process, specifically its FOIA logs , for a few years. We were wrong.

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FDA Governance 52

Health Law Advisor

MAY 2, 2023

In prior posts here and here , I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. Chances of Success by Topic Given those topics, I wanted to understand which topics are likely to succeed in getting information from FDA. Here’s what I found. Who is asking what?

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FDA 52

Health Law Advisor

JANUARY 31, 2023

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact.

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FDA 52

HIT Consultant

MARCH 6, 2024

This influx of capital marks a pivotal moment in BHT’s mission to reshape bone health for postmenopausal women, closing right in time for de novo FDA clearance. Presently, more than 64 million individuals in the US are grappling with osteopenia and osteoporosis.

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C&M Health Law

OCTOBER 29, 2021

Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices. The FDA is accepting public comment on these principles on an ongoing basis.

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FDA 52

Bill of Health

OCTOBER 17, 2023

Epigenetic changes from environmental exposures, cell-to-cell signaling behaviors, and the mutations present in diseased cells all profoundly inform how cells behave in whether and how they code the instructions that DNA offers. Disease isn’t always “written in the stars” for patients.

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FDA HIPAA Informed Consent 277

Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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FDA Nursing Homes Compliance COVID-19 52

Mobi Health News

MARCH 16, 2021

The company’s digital therapy CureSight presents a new treatment method for amblyopia, also known as lazy eye, that doesn’t require patching. .

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FDA 75

Bill of Health

JANUARY 26, 2024

Besides grants for “psychedelic” research, the FDA just released draft guidance on considerations for psychedelic clinical investigations with an ambiguous definition of what is considered to be a “psychedelic.” When we discuss FDA clinical trials , we’re talking big money , so clarity matters here.

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FDA Governance Health Insurance 191

Hall Render

SEPTEMBER 6, 2023

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. The presentation of study data continues to be a major focus for OPDP.

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FDA 40

Bill of Health

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

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Hall Render

JULY 14, 2023

On June 7, 2023, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first Untitled Letter of the year regarding violative promotional materials for a prescription drug indicated for the treatment of endogenous hypercortisolemia (high cortisol) in adults with Cushing’s syndrome.

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FDA Compliance 40

Healthcare IT Today

JANUARY 8, 2024

It maintains the most rigorous security certifications and holds over 100 patents and numerous regulatory registrations, including FDA clearance and CE marking. A Certified B Corporation, Volpara is the preferred partner of leading healthcare institutions around the world. For more information, visit volparahealth.com.

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FDA Hospitals 98

Bill of Health

APRIL 8, 2022

The Food and Drug Administration has authorized studies of psychedelics , including on a “breakthrough therapy” designation, but these drugs may not be handled by persons without a Drug Enforcement Administration license and outside an FDA approved setting. Or a specific ban on microdosing, inside or outside of work hours?

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Licensing FDA Governance 293

HIT Consultant

OCTOBER 31, 2023

Annalise Triage Overview Annalise Triage includes an array of 12 FDA-cleared findings, including 5 for chest X-ray (CXR) and 7 for non-contrast head CT (CTB). AI-enhanced worklist triaging has been shown to decrease both the time a radiologist needs to read a report, and the time from request until a report is available for critical cases.

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Healthcare IT News - Telehealth

MAY 9, 2022

The state already required physicians to be physically present with patients when providing medication for abortion. In December 2021, the FDA opted to permanently modify its regulations, thereby enabling abortion via telehealth in more than half the country. Now, the new law adds criminal penalties for failing to do so. ON THE RECORD.

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COVID-19 FDA Telemedicine Hospitals 153

Healthcare IT Today

JANUARY 5, 2024

The app-based digital therapeutics are the only FDA-authorized app-based treatments for SUD and OUD, respectively. In recently presented data , reSET and reSET-O users saved Massachusetts $2,011 per user in healthcare resource-related costs.

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FDA Medicaid Medicaid Hospitals 101

Bill of Health

FEBRUARY 27, 2024

There is a common and problematic misconception that colonization was an isolated historical event and that the present is somehow divorced from its precedent. To explore how colonization drives health inequities, we have to acknowledge the causal relationship between what is past and what is present and think critically about colonization.

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Governance FDA World Health Health Outcomes 120

Healthcare It News

FEBRUARY 1, 2022

Lastly, artificial intelligence (AI) gains significance and undergoes stronger scrutiny procedures in the US with more than a hundred new AI and machine learning (ML) based device approvals by the FDA. The new BCG Digital Ventures report is the second after its initial launch in 2021. ” THE LARGER TREND.

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COVID-19 FDA Health Insurance Doctors 216

HIT Consultant

JUNE 23, 2022

The incubator will culminate in a demo day, with the cohort presenting their solutions to a panel of industry stakeholders. The second track will identify an additional eight startups to participate in a high-touch, eight-week incubator concentrated on curating introductions to key potential U.S.

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Florida Health Care Law Firm

MARCH 22, 2022

One of the criteria for these exemptions is that the Secretary has not identified the drug, by regulation, as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. During this time, cBHRT drugs were not added to the list.

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Healthcare IT News - Telehealth

JANUARY 19, 2021

Experts have repeatedly predicted that telehealth would present a major challenge for healthcare cybersecurity in the coming year. "FDA does not regulate telemedicine," she reminded co-panelists. But "if there's one thing FDA has really learned … it's that everybody has to be doing their part."

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Telemedicine Ransomware FDA COVID-19 217

Healthcare It News

FEBRUARY 1, 2022

Lastly, artificial intelligence (AI) gains significance and undergoes stronger scrutiny procedures in the US with more than a hundred new AI and machine learning (ML) based device approvals by the FDA. The new BCG Digital Ventures report is the second after its initial launch in 2021. ” THE LARGER TREND.

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COVID-19 FDA Health Insurance Doctors 207

Healthcare IT News - Telehealth

MARCH 14, 2022

Electronic Caregiver is presenting Addison the Virtual Caregiver in addition to its other RPM technology alongside care management company MD Revolution in HIMSS Booth 4109. Virtual-reality telemedicine. Individual patients can purchase "Flow Health" for $599.

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FDA Doctors Telemedicine Health Outcomes 147

Healthcare IT News - Telehealth

AUGUST 2, 2022

" There are currently no FDA-approved OTC medications for hypertension. "For instance, if an individual is diagnosed with high blood pressure by a One Medical doctor, will he later be advertised over-the-counter blood pressure medications whenever he shops at Whole Foods Market?"

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FDA HIPAA Doctors 128

HIT Consultant

MARCH 19, 2023

The unprecedented scale of the public health and marketing campaigns, the high prevalence of MCI in the population over 60 years old, and people’s fear of dementia will combine to create a tsunami of patients presenting to their healthcare providers seeking testing and treatment. billion marketing the medication.

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US Department of Health and Human Services Hospitals COVID-19 FDA 98

HIT Consultant

JUNE 30, 2022

This is also driven by the use of home wearable solutions and increased awareness of heart health resulting in more patients presenting for additional diagnosis. Apple – Apple first gained FDA approval in September 2018 for its app for the detection of atrial fibrillation (AF) or sinus rhythm using the Apple Watch Series 4 onward.

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COVID-19 FDA Telemedicine Hospitals 97

HIT Consultant

FEBRUARY 1, 2024

The challenges of pharma influencing also present avenues for influencers to bridge the communication gap between brands and consumers. According to the FDA’s website , here are some regulations: Ads must be truthful. Must accurately communicate both the benefits and risks of medications.

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Pharmaceutical Industry FDA Public Health Regulatory Compliance 111

HIT Consultant

OCTOBER 21, 2022

US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. If we have a use case that is helpful for that, we ask for permission from the previous customer to bring that out and present it. Rolland Carlson, CEO of Immunexpress.

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Hospitals FDA Compliance COVID-19 98

Bill of Health

MARCH 20, 2023

In February 2023, the FDA granted its first Orphan Drug Designation to a drug discovered and designed using AI; Insilico Medicine plans to begin a global Phase II trial for the drug “early” this year.

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FDA 313

Bill of Health

NOVEMBER 3, 2023

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. Medical malpractice could occur for two reasons.

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