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On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19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. Comments on the draft guidance are due on March 23, 2022. Guidance Overview.

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SQA

AUGUST 8, 2023

In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations. mg Strengths) Due to Possible Device Failure, 05 May 2023 Bausch Health, Canada Inc. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023.

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SQA

MAY 24, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

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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

DECEMBER 10, 2021

Regulators in Europe have updated their implementation plan for sweeping new in-vitro diagnostic (IVD) medical device regulations taking effect in 2022. Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. In-house devices. European Medicines Agency (EMA).

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Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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Healthcare Law Blog

JANUARY 11, 2022

On January 10, 2022, the U.S. Department of Health & Human Services, Department of Labor, and the Treasury (“Tri-Agencies”) published guidance about how health plans and health insurance issuers must reimburse OTC COVID-19 tests. 10, 2022) at 5.

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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

SQA Regulatory Surveillance Summary for July and August 2022. Health Canada. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. Taro Pharmaceuticals Inc.

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Healthcare Law Blog

OCTOBER 25, 2023

Effective January 1, 2022, an individual in Oregon who acts as a pharmaceutical representative for more than 15 days during the calendar year must have, and renew annually, a license from the Department of Consumer and Business Services (“DCBS”). ix] Nevada.

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Healthcare Law Blog

AUGUST 25, 2022

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part D benefit redesign, as well as myriad other updates. For more information on this final rule, see our blog.

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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

FEBRUARY 26, 2024

Ltd, a Contract Research Organization (CRO) in Kharadi, India, was subject to a Good Clinical Practice (GCP) inspection in November 2020 and November 2022 by the Spanish Agency for Medicines and Medical Devices (AEMPS). Schedule 10 lists substances of such danger to public health as to warrant their prohibition from supply and use.

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Hall Render

MARCH 16, 2022

On Tuesday, March 15, 2022, President Biden signed into law the Consolidated Appropriations Act of 2022 ( H.R. 2471 ) that funds the federal government for the remainder of FY 2022. An overview of the FY 2022 funding bill and a summary of its health care-related provisions can be found below. million increase.

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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. GlaxoSmithKline PLC , 2022 WL 17338047 (E.D.N.Y. 29, 2022), which (if allowed to stand) imperils everything that Congress and the Supreme Court accomplished through the Vaccine Act. Merck & Co.

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Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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Drug & Device Law

FEBRUARY 8, 2024

As insightful and modest as the Blog can be, we are not infallible. So, we present two posts in one, the latter of which overlaps some with a prior post by a new Blog contributor. So, we present two posts in one, the latter of which overlaps some with a prior post by a new Blog contributor. 23-51067, 2024 WL 244938 (5th Cir.

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Drug & Device Law

JUNE 28, 2022

Jackson Women’s Health Org. , 2022 WL 2276808 (U.S. June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. Congress required the FDA to “protect the public health” by making sure that “drugs are safe and effective.”

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