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. The application/notification must be submitted via the EUDAMED database (Article 69 IVDR).

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Health Law Advisor

MARCH 1, 2023

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing. [1]

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Healthcare IT Today

MAY 3, 2023

The following is a guest article by Steven LeBoeuf, Ph.D. , The following is a guest article by Steven LeBoeuf, Ph.D. , Moreover, the market for FDA-approved BP monitoring solutions that encourage routine measurements is well into the billions [ 22 , 23 ]. The existential question remains: What gives?

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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. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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SQA

SEPTEMBER 2, 2022

Compared to the 2016 revised version, the draft of the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019. United States Food and Drug Administration (FDA) – Regulations and Guidances.

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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. The addition of Annex 2, which describes the CPCA for N -nitrosamines.

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FDA Compliance Licensing World Health 40

SQA

DECEMBER 10, 2021

Guidance for Notified Bodies such as batch testing and Article 110(3) of the IVDR. Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The EMA and FDA have agreed to the following principles for the pilot program. Performance evaluation and expert panels.

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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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AIHC

FEBRUARY 2, 2022

Written by: AIHC Blogger This article is to communicate information from the Health Resources & Services Administration (HRSA) regarding the coding of COVID-19 claims for uninsured patients. COVID-19) for discharges occurring on or after April 1, 2020, through the duration of the COVID-19 public health emergency period. •

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COVID-19 Vaccine COVID-19 Medicare Medicare 52

SQA

OCTOBER 18, 2022

Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada.

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US Department of Health and Human Services FDA COVID-19 Compliance 40

AIHC

AUGUST 2, 2022

Written by: AIHC Blogger This educational article is based on clinical information as of the publication date and primarily based on government and coding guidelines to assist coders, billers, clinical documentation improvement professionals and auditors address appropriate documentation for filing claims in the United States.

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US Department of Health and Human Services FDA Licensing Compliance 98

SQA

FEBRUARY 26, 2024

” If the product is prohibited in Brazil, a notice of infraction is drawn up for smuggling of goods (Article 334 A, item II, of the Criminal Code), which is then sent to the Public Prosecutor’s Office for criminal investigation. After this period, the product is characterized as an “abandoned commodity.”

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FDA Compliance COVID-19 Public Health 52

Kaiser Health News

APRIL 6, 2022

Other graduates interviewed for this article talked about using the moving skills or commercial driving licenses they gained to obtain full-time jobs. Only 12 facilities are licensed to prescribe buprenorphine. Some said they’re buying houses and starting families — successes they credit to their experience in the program.

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Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. C-8 Personal Injury Litigation , 87 F.4th 4th 315 (6th Cir.

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