SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

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AIHC

JUNE 6, 2023

OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. Can ChatGPT Replace a Physician? The article asks the same question – can ChatGPT replace physicians?

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Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

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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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Bill of Health

NOVEMBER 15, 2023

health care system, but that are especially present for behavioral health needs like substance use, and are exacerbated by other challenges related to stigma, lack of employment, and fragmented or nonexistent care coordination. This reality reflects structural, policy, and legal misalignments common to the entire U.S.

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Jane Sarashon

DECEMBER 19, 2022

For over ten years, digital health technology has been a fast-growing area at the annual CES , the largest convention covering consumer electronics in the world. Gary’s Book Club featured my HealthConsuming: From Health Consumer to Health Citizen at the 2020 CES. At CES 2023, sleep is a major segment.

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SQA

DECEMBER 16, 2022

The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of 01 March 2023. More than 6,000 comments led, quite unusually, to a second draft for renewed public comment in 2020. implementation date: 01 January 2023). European Commission (EC). Thin Layer Chromatography.

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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’. effective as of 01 July 2023. The European Pharmacopoeia (Ph.

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SQA

DECEMBER 10, 2021

It is anticipated that ANVISA will review stakeholder feedback on the public consultation through November 2021, then issue a final regulation on UDI in December 2021. Based on these projections, Class IV device registrants would face a December 2023 deadline for UDI compliance. European Medicines Agency (EMA). The EMA and the U.S.

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Healthcare Law Blog

OCTOBER 25, 2023

As of October 1, 2023, a pharmaceutical manufacturer that employs individuals as pharmaceutical representatives must register as a pharmaceutical marketing firm with the CT DCP and renew their registration annually, and by no later than June 30 th of each year. FOOTNOTES [i] See Connecticut Public Act No. 1)(2) (2023). [iv]

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

Healthcare Law Blog

AUGUST 25, 2022

The drug publication date for 2026 will be chosen by September 1, 2023. After 2026, the timing for publication is standardized – the February 1 st two years prior to the price applicability date will be the drug publication date. For more information on this final rule, see our blog. Negotiation-Eligible Drugs.

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SQA

FEBRUARY 26, 2024

The action was held from 26 to 28 September 2023, at the city’s international entry points. ANVISA Publishes New Measures to Prohibit Cosmetic Products Used in Injectable Form, 10 October 2023 ANVISA published two resolutions that suspended the trade, distribution, manufacture, advertising, and use of products from PHD Cosméticos Ltda.

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FDA Compliance COVID-19 Public Health 52

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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Nursing Homes US Department of Health and Human Services Nurses COVID-19 40

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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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. Executive Health Resources, Inc. , Another year bites the dust.

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Drug & Device Law

MARCH 2, 2023

Commentators beyond this Blog have described how this bent affects contraceptive choice and public health. 1:22-CV-00197-LMM, 2023 WL 2111346 (N.D. 17, 2023), however, left us scratching our heads. 2023 WL 2111346, *6. The recent decision in Blevins-Ellington v. CooperSurgical, Inc. ,

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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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