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Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.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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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To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works.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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Florida Health Care Law Firm

MAY 5, 2022

The FDA does not regulate essential oils, just like it doesn’t regulate herbs or supplements. That means that there is no FDA approval for any essential oil. But if they say that their product is FDA-approved to do something specific, that is incorrect and they are open to fines and could be shut down.

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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

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

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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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

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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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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VW Health Care Law Blog

JUNE 29, 2020

One unintended consequence of COVID-19 has been the paradigm shift within the healthcare industry which has turned to prioritize value-based, patient centric remote monitoring solutions and non-contact technologies.

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Healthcare IT Today

JANUARY 11, 2024

Almost all of their new devices are regulated by the FDA as medical devices. Contact us here or on Twitter at @hcitoday. .” The impact can be widespread, because only 16% of people with diabetes get their annual foot exam, but the scale can identify problems with their feet early. Tell us what you think.

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Exeed Regulatory Compliance

FEBRUARY 25, 2020

Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification. the FDA expects for interoperable devices.

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Healthcare IT Today

APRIL 8, 2024

Clients of both companies can expect a seamless transition during the integration of the two companies and can continue to contact their current representatives for support needs. Widespread use of effective screening followed by appropriate interventions and monitoring will benefit hundreds of millions of patients worldwide.

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Healthcare IT Today

MARCH 20, 2023

At the same time, the FDA wants implementations to hit the market faster and CMS rewards institutions for interoperability not just for installing the right products, but only when the data sharing is actually successful. Contact us here or on Twitter at @hcitoday. Tell us what you think.

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Healthcare IT Today

DECEMBER 1, 2023

” The FDA, VA, and others are using synthetic data. Contact us here or on Twitter at @hcitoday. Thus, you can use the synthetic data to compare characteristics that matter to you. Rubel calls this synthetic data a “precision cohort” and says it “tells the same story the real patient data would have told.”

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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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Natalia Mazina

AUGUST 16, 2022

Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug. If you need assistance with drafting such informed consent and release, please contact our office or your healthcare attorney.

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HIT Consultant

DECEMBER 14, 2021

Xandar Kardian’s XK300 Autonomous Health Monitoring Solution is the world’s first and only commercially available, contact-free, continuous VSM (vital sign monitoring) system that is FDA 510(k) cleared as a class II medical device. The occupancy sensor market is forecasted to be a $3.9 billion market by 2024.

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Exeed Regulatory Compliance

OCTOBER 26, 2020

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. The FDA has just approved a new antiviral drug, Remdesivir from Gilead Sciences , for treating COVID-19 patients needing acute care in a hospital. FDA is requiring additional post-market studies.

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Healthcare IT Today

DECEMBER 22, 2022

Their offering includes: An FDA-cleared handheld solution for remote physical examinations and diagnosis. Contact us here or on Twitter at @hcitoday. TytoCare , a virtual care company, recently launched its Home Smart Clinic that enables primary care from home. Tell us what you think.

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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. Contact us and let us know how we can help.

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MedTrainer

FEBRUARY 19, 2024

Exposure incidents: Unanticipated events that involve contact with blood or other bodily fluids that can potentially cause harm. When healthcare professionals and organizations report equipment malfunctions to the correct authorities, the FDA may recall these items based on increased reports. Contact us to learn more.

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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. Your primary Hall Render contact.

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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. On June 6, 2023, the U.S. Special thanks to Summer Associate, Ben Murphy, for his assistance with the preparation of this Article.

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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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Compliancy Group

NOVEMBER 2, 2022

The Food and Drug Administration (FDA) recognized this when they released guidance for medical device manufacturers to increase cybersecurity. Medical device manufacturers must submit a ‘Cybersecurity Bill of Materials’ during premarket reviews to the FDA for review. Patch Management.

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Healthcare Law Today

FEBRUARY 1, 2022

Improves clinical trials by requiring the Food and Drug Administration (FDA) to issue guidance on the use of digital health technologies in clinical trials; decentralized clinical trials; and other innovative designs to support development of new drugs. Senators Murray and Burr expect the legislation to progress this year.

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Natalia Mazina

JUNE 26, 2023

counterfeit, unapproved, or potentially dangerous)) Notification (trading partners must notify FDA if they suspect that the product is illegitimate). The Act sets six compliance deadlines. The last one is coming up on November 27, 2023 and pertains to enhanced product tracing.

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Health Law Pulse

MARCH 30, 2022

Users are first prompted to select whether they have tested positive for COVID-19 or whether they had close contact with someone who had COVID-19. This recommendation came after the FDA gave authorization for this fourth round for older and immunocompromised individuals. Only Pfizer and Moderna are approved for a second booster.

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Total Medical Compliance Resources

MARCH 19, 2024

Agencies such as the CDC, FDA, and the ADA have issued guidance for dental offices on maintaining DUWL. Contact the manufacturer of your dental units to find out which method(s) of treatment would work best for your dental unit. Dental unit waterline (DUWL) maintenance and monitoring remains an area of concern for dental facilities.

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Exeed Regulatory Compliance

JULY 20, 2020

The Accuracy of Covid-19 Antibody Tests As we write this blog, the FDA has authorized 30 different antibody tests for Emergency Use. The second risk is related to the FDA Emergency Use Authorization process itself. Under normal circumstances, FDA would require a lot more data on clinical validation before approving these tests.

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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. Testing is critical to identify infected individuals, isolate them and contact trace other potentially infected individuals. More than 250,000 cases of infection and over 10,000 deaths have been reported.

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Exeed Regulatory Compliance

JULY 31, 2020

In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease. If the answer is yes, then FDA may not issue an EUA.

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HIT Consultant

DECEMBER 15, 2021

Aidoc has seven FDA-cleared solutions and has won numerous awards including the prestigious UCSF ‘Best New Health Application of AI’ award and TIME’s 50 most genius companies. BELKIN Laser , a clinical-stage medical device company developing a disruptive automated one-second laser treatment for glaucoma, raised $13.75

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Dot Compliance

JUNE 16, 2022

The two most relevant quality regulations for medical device manufacturers are the FDA 21 CFR Part 820 and the ISO 13485:2016. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance. The FDA 21 CFR Part 820 is the mandatory standard for medical devices distributed in the US.

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Hall Render

JANUARY 11, 2023

The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Your primary Hall Render contact. Regulatory Landscape.

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Healthcare IT Today

APRIL 14, 2024

CloudWave renewed its partnership with the FDA to share threat intelligence data for medical device security. Collette Health released new monitoring hardware that includes a “follow feature” to help virtual observers maintain contact with a patient remotely. RPM vendor Tenovi launched a cellular-connected smart pillbox.

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