Bill of Health

APRIL 28, 2023

What do a MacArthur Genius award winner, several health law professors at top schools, executive directors of leading health law centers, an associate chief counsel of the FDA, and partners and associates at top health care law firms all have in common? The Petrie-Flom Center Student Fellowship !

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The Health Law Firm Blog

JULY 20, 2023

Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On April 14, 2022, the U.S. The test, made by Texas-based company, InspectIR Systems, is authorized for those [.]

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Hall Render

AUGUST 31, 2023

Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a decision by a District Court judge in Texas that would have suspended the FDA’s approval of mifepristone. Jackson Women’s Health.

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Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S. study sponsor, regulatory agencies, etc.)

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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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Hall Render

FEBRUARY 7, 2023

Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”).

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Hall Render

MAY 11, 2022

Earlier this year, the Food and Drug Administration (“FDA”) announced a Proposed Rule regarding national standards for the licensing of prescription drug wholesale distributors (“Wholesale Distributors”) and third-party logistics providers (“3PLs”). Accordingly, FDA is proposing the withdrawal and replacement of the current 21 C.F.R.

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Hall Render

SEPTEMBER 8, 2023

Under the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations , “drug promotional labeling and prescription drug advertising must be truthful and non-misleading, convey information about the drug’s efficacy and its risks in a balanced manner and reveal material facts about the drug.”

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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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The Health Law Firm Blog

APRIL 24, 2022

Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On April 14, 2022, the U.S. The test, made by Texas-based company, InspectIR Systems, is authorized for those [.].

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Hall Render

JULY 29, 2022

Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. SIPs are reviewed and authorized by the FDA and managed by States or Indian Tribes (“SIP Sponsors”). In May 2022, the U.S. Brief Discussion.

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McBrayer Law Blog

AUGUST 25, 2021

due to the highly contagious Delta variant, the Food and Drug Administration (FDA) has announced that the Pfizer-BioNTech vaccine, one of three that has been available under Emergency Use Authorization, has achieved full approval.

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Exeed Regulatory Compliance

APRIL 2, 2020

A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices. One such example is the Control-IQ technology , a software product recently classified by the FDA as a Class II medical device.

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Exeed Regulatory Compliance

AUGUST 3, 2020

Understanding the Available Diagnostic Tests As of this writing, the FDA has authorized 187 different tests, including 154 RT-PCR molecular diagnostic tests for COVID-19. FDA allowed physicians to order one of the authorized tests if they suspected COVID-19 even when the patient did not show any symptoms. CONTACT US.

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Bill of Health

SEPTEMBER 13, 2023

They each will undertake a year-long research project with mentorship from Center faculty and affiliates, and also will blog here at Bill of Health regularly. His current research focuses on tensions between the patent incentive system, the FDA approval process, and insurance carriers. Keep an eye out for their bylines!

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Bill of Health

SEPTEMBER 22, 2022

They each will undertake a year-long research project with mentorship from Center faculty and affiliates, and also will blog here at Bill of Health regularly. Aparajita also blogs on SpicyIP. Sanjay’s research interests include pharmaceutical competition, FDA regulatory reform, and health care coverage.

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Exeed Regulatory Compliance

FEBRUARY 25, 2020

In this blog, we are focusing on a recently cleared innovation in the challenging space of diabetes management that highlights some of the key ingredients of success for innovative, connected medical devices. the FDA expects for interoperable devices.

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Bill of Health

JUNE 5, 2023

This blog post will examine the liability risks for health care providers and AI providers alike as ChatGPT and similar AI models increasingly are used for medical applications. Food and Drug Administration (FDA). But what happens when AI gets things wrong?

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Dot Compliance

MAY 3, 2024

In this blog post, we’ll explore how quality management is essential for meeting regulatory standards and maintaining the efficacy, safety and high quality of pharmaceutical products. The FDA ensures that drug manufacturing processes align with these CGMP objectives. Governing bodies such as the U.S.

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VW Health Care Law Blog

JUNE 29, 2020

This is not to say that digital technologies … Continue reading Coronavirus is Deregulating Healthcare One FDA Guidance At a Time. COVID-19 has created a demand for digital health technologies to provide relief for public health professionals and individuals alike.

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Health Populi

FEBRUARY 28, 2021

With a third vaccine approved by the FDA for licking COVID-19, brought to market by Johnson & Johnson, the U.S. And Excess Deaths” in my latest post for Medecision’s Liberation blog. can expect an uptick in vaccinations among fellow health citizens. That’s such welcome news and a positive outlook for a healthier 2021.

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Exeed Regulatory Compliance

MARCH 9, 2020

Here is an update on recent FDA activities. Cybersecurity of medical devices is on FDA’s radar! Just last week, the FDA issued a safety communication about the recently identified SweynTooth family of cybersecurity vulnerabilities which may affect medical devices. Please click on the video link below.

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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. Hall Render blog posts and articles are intended for informational purposes only.

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Healthcare IT News - Telehealth

MARCH 15, 2023

FDA clears AI-driven remote wheeze detection by TytoCare TytoCare, a virtual care company, announced today that it has received U.S The company's FDA-approved handheld remote examination device and AI analyze recorded lung sounds to help clinicians diagnose respiratory conditions remotely.

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Health Law Advisor

AUGUST 2, 2022

My goal in nearly every device submission is to try to get through the FDA process with as little attention from FDA as possible. But when a seasoned person looks at it who has experience with FDA, their first thought is, do I really want FDA more involved in the process? Free advice! That’s not a criticism.

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Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. Not to spill the beans, but if you think that, you’d be wrong.

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MedTrainer

JANUARY 12, 2024

In this blog post, we’ll outline who regulates healthcare compliance, how rules are enforced, and why organizations need a robust compliance platform to stay in the good graces of regulators. Food and Drug Administration (FDA): The FDA regulates compliance in pharmaceuticals, medical devices, and biotechnology products.

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MedTrainer

FEBRUARY 19, 2024

In this blog, we’ll answer the question “why is incident reporting important in healthcare?,” When healthcare professionals and organizations report equipment malfunctions to the correct authorities, the FDA may recall these items based on increased reports. A doctor performs surgery on the wrong body part.

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Exeed Regulatory Compliance

JULY 31, 2020

As we write this blog, over 60,000 new infections are being reported on a daily basis in the United States, with a cumulative total of over 4 million cases and over 150,000 deaths reported since the pandemic first began here. How Emergency Use Authorization of Medical Products Helps Provide Relief During a COVID-19 Major Crisis.

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Healthcare IT News - Telehealth

MARCH 15, 2023

FDA clears AI-driven remote wheeze detection by TytoCare TytoCare, a virtual care company, announced today that it has received U.S The company's FDA-approved handheld remote examination device and AI analyze recorded lung sounds to help clinicians diagnose respiratory conditions remotely.

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Health Law RX

FEBRUARY 13, 2023

On January 3, 2023, the Food and Drug Administration (“FDA”) modified its risk evaluation and mitigation strategy for mifepristone, an abortion drug that is utilized in tandem with misoprostol to terminate an early term pregnancy, in part to broaden the ability of retail pharmacies to dispense that drug ( FDA Action ).

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Hall Render

OCTOBER 18, 2022

Defendant pharmaceutical manufacturers applied for and received approval from the FDA to manufacture Gamunex at a facility converted for that purpose. FDA regulations require current Good Manufacturing Practices [cGMP] to be met or the drug shall be deemed adulterated and prohibited from sale. United States ex rel. at *1 & fn.

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Hall Render

JUNE 29, 2023

Food and Drug Administration (“FDA”) released draft guidance (“Draft Guidance”) updating Good Clinical Practices (“GCPs”) recommendations for interventional clinical trials involving human subjects. Hall Render blog posts and articles are intended for informational purposes only. On June 6, 2023, the U.S.

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Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. At the time of writing this blog, the novel coronavirus is rampant in over 150 countries across the world. FDA policy issued on 29 February 2020 , provided the impetus to the MedTech industry which has risen to the occasion.

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The Digital Health Corner

NOVEMBER 29, 2023

The objective of my blog, which began in 2011, was and remains educating the reader (clinicians, healthcare IT community, patients and caregivers, and other healthcare stakeholders about digital health technology and how it is relevant to the changing healthcare environment. It has been a long time since my last post of 2018.

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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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Healthcare IT Today

FEBRUARY 25, 2024

The news isn’t all good, as ONC noted in a blog post , as 68% of vendors are also using some form of proprietary APIs as well. X-trodes receives FDA 510(k) clearance for Smart Skin , its wireless wearable for monitoring brain, heart, eye, and muscle activity.

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