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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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview.

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VW Health Care Law Blog

JUNE 29, 2020

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

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Bill of Health

MARCH 28, 2022

Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2. By James Lytle. Recent guidance from the U.S. less likely to receive the treatment than whites.

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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. can expect an uptick in vaccinations among fellow health citizens. And Excess Deaths” in my latest post for Medecision’s Liberation blog. That’s such welcome news and a positive outlook for a healthier 2021.

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Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency.

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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. It is a public health emergency of massive scale that has affected nearly all aspects of our life.

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SQA

SEPTEMBER 2, 2022

Ma rketing authorization holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’. United States Food and Drug Administration (FDA) – Regulations and Guidances.

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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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SQA

MARCH 25, 2021

United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency, January 2021.

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SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

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SQA

AUGUST 2, 2021

Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. b) and 320.31(d)(3)).

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Health Populi

JANUARY 31, 2018

Omron is submitting the HeartGuide watch for FDA review this year and once cleared, the device will be the first blood pressure monitor that accurately reads BP right from the wrist. Omron seeks to jump that hurdle through FDA clearance. Here is Omron’s blog written for #CES2018 on Going for Zero.

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Health Law Advisor

AUGUST 1, 2023

Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look at the data. To tie the MDR data with the recall data, we are using K numbers, the numbers that FDA assigns during the course of a 510(k) review.

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SQA

DECEMBER 10, 2021

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

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Exeed Regulatory Compliance

APRIL 6, 2020

Recently, the FDA has authorized the emergency use of the Battelle CCDS Critical Care Decontamination System , which uses vapor phase hydrogen peroxide to decontaminate N95 or N95-equivalent respirators for reuse by healthcare personnel. This is one of the criteria used by the FDA for granting the Emergency Use Authorization.

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Jane Sarashon

DECEMBER 27, 2021

I covered this announcement in the Health Populi blog at the time, and today want to double-down on the significance of Ford’s leading presence at #CES2022. . “This marks the first time in CES history that a healthcare company will take the mainstage for a keynote at the show,” CTA’s press release stated.

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Health Populi

MAY 30, 2018

Data provided to the FDA from patients who have used the product demonstrate a variety of side effects including but not limited to nausea, headache, slowed breathing, and amnesia — but not racism as far as the post-marketing surveillance has revealed. .”

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Hall Render

MARCH 16, 2022

The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. An overview of the FY 2022 funding bill and a summary of its health care-related provisions can be found below. .

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SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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Healthcare Law Blog

JANUARY 11, 2022

As first announced by President Biden on December 2, 2021 , the Biden Administration explained that health plans and health insurance issuers (meaning the commercial insurance market) would be required to reimburse individuals who purchase OTC COVID-19 tests during the public health emergency. 23, 2020) at 6.

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SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. United States Food and Drug Administration (FDA) – Regulations and guidance. Computer Software Assurance for Production and Quality System Software, 13 September 2022.

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Jane Sarashon

DECEMBER 19, 2022

Heart health has become mainstream in digital health at CES, with wrist-tracking bands embedded various aspects of heart tracking, ear buds growing heart monitoring capabilities, and FDA-cleared blood pressure readings from the wrist from OMRON and Withings. In the meantime…welcome to your new HealthQuarters!

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SQA

OCTOBER 18, 2022

The UK sees the plans as an opportunity to introduce new regulations after Brexit in order to strengthen the public health sector. Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus.

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SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products.

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SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

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SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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Health Populi

JANUARY 2, 2020

Healthcare is getting serious at #CES2020, blurring into the medical and FDA regulated turf which Omron pioneered last year launching its 80+-patented blood pressure watch, the HeartGuide. Here is my pre-look into what I expect to explore at #CES2020 through my health/care-is-everywhere lens….

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Healthcare Law Blog

AUGUST 25, 2022

Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. For more information on this final rule, see our blog. Negotiation-Eligible Drugs. The final rule will not be implemented or enforced prior to January 1, 2032.

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Healthcare Law Blog

JANUARY 9, 2024

On the healthcare services side, NVIDIA mentioned GI Genius, which has an FDA approved AI-assisted endoscopy device that provides real-time identification and decision support to the provider conducting the endoscopy. We can make a difference if we as a society choose to act. Something for CMS and all of us to ponder!

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AIHC

JUNE 6, 2023

AIHC recommends reading OpenAI’s blog posted about the data breach: [link] Conclusion Medical software dealing with patient data must be secure and HIPAA compliant. So, it goes without saying that AI-driven medical billing and coding applications that process critical financial and health data must meet these standards.

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AIHC

JUNE 6, 2023

AIHC recommends reading OpenAI’s blog posted about the data breach: [link] Conclusion Medical software dealing with patient data must be secure and HIPAA compliant. So, it goes without saying that AI-driven medical billing and coding applications that process critical financial and health data must meet these standards.

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MedTrainer

OCTOBER 27, 2020

Each nursing home will receive one shipment that includes supplies to facilitate baseline testing and enable a pathway to conduct ongoing testing according to public health guidelines. To be eligible, nursing homes must have a current CLIA Certificate of Waiver and meet certain epidemiological criteria.

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Healthcare Law Blog

OCTOBER 25, 2023

As with Oregon’s requirements, licensees in Chicago must also complete an educational course for both the initial license as well as any subsequent renewals, which are subject to audit by the Chicago Department of Public Health. Violations of the educational requirements can be subject to fines $1,000 to $3000 per day of violation. [ix]

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Hall Render

APRIL 14, 2023

NATIONAL 94% of Organizations Experienced a Cyberattack in 2022 AHA blog: Strengthening crisis management in rural health care Biden signs bill ending Covid-19 national emergency Cancer drug shortages are creating dire circumstances for some patients CMS Releases FY24 IPPS Proposed Rule, Seeks to Boost Rates by 2.8%

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SQA

JANUARY 25, 2021

The Metformin HCl Extended-Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued in September 2020. Nostrum Laboratories, Inc.

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Drug & Device Law

DECEMBER 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. Just as vaccination was one of the greatest public health accomplishments of the previous century, the Vaccine Act was one of Congress’ most effective limits on the destructive use of mass tort litigation.

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