Healthcare Law Blog

AUGUST 9, 2023

8] The court in Members of the Medical Licensing Board of Indiana, et al. 20 will take effect, including: requirements for all surgical abortions to take place in hospitals; licensing requirements for abortion clinics; expanded practice authority for certified nurse midwives; and new provisions for the “safe surrender” of an infant. [22]

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SQA

DECEMBER 16, 2022

SQA Regulatory Surveillance Summary for September and October 2022. ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. 30 of 2022.

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FDA Compliance COVID-19 Licensing 40

SQA

SEPTEMBER 2, 2022

SQA Regulatory Surveillance Summary 2022 – June. Brazil’s ANVISA Repeals Medical Device Regulations Related to The Coronavirus Pandemic, 20 May 2022. ANVISA Extends Brazilian Good Manufacturing Practice Requirements to More Medical Device Manufacturers, 27 May 2022 . By Laurel Hacche & Debra Cortner SQA Associates.

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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. It addition, the company did not report one or more recalls.

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FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2023

National Medical Products Administration (NMPA) China GLP Certification Regulation Takes Effect, 01 July 2023 After consulting on the draft in 2022, the NMPA issued the Administrative Measures for Drug Good Laboratory Practice (GLP) Certification earlier this year.

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FDA Compliance Licensing World Health 40

Healthcare Law Blog

JANUARY 12, 2022

Yesterday, Oak Street Health talked about its recent addition of behavioral health support and its launch of a comprehensive virtual care network in 2022. A biosimilar is a biologic that is highly similar to, and has no clinically meaningful differences from, an existing biologic medicine that is already approved by the FDA.

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US Department of Health and Human Services Doctors Nurses Medicare 52

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”).

Licensing 52

Licensing Compliance FDA Public Health 52

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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FDA Compliance Public Health Hospitals 52

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

SQA Regulatory Surveillance Summary for July and August 2022. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. 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. Health Canada.

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

Healthcare Law Blog

AUGUST 25, 2022

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 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.

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

Healthcare Law Blog

NOVEMBER 13, 2023

Please refer to our January 5, 2023 , November 4, 2022 and May 16, 2022 blog posts for more information. 8] See Dual Eligible Special Needs Plan “Look-Alike” Transitions for Contract Year 2022 , Ctrs. None of these changes addressed how MA organizations and Part D sponsors compensate agents, brokers and other TPMOs.

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Medicare Medicare Medicaid Medicaid 59

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).

FDA 52

FDA Compliance COVID-19 Public Health 52

Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. May 17, 2023 : The Fifth Circuit heard oral arguments from the FDA, Danco, and the Plaintiffs. Had the U.S.

FDA 52

FDA Governance Telemedicine Licensing 52

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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FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. 2022 WL 610276 (C.D. 31, 2022), fell into our laps. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., Medtronic Inc. Medtronic, Inc. ,

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Drug & Device Law

JUNE 15, 2022

It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on this Blog. It’s not like such tests have been a product liability hotbed. In fact, when searched for that term, we received zero results. —No b) Exceptions.—Subsection

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FDA Governance Licensing Compliance 52

Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. 2022 WL 970681 (N.D. 3d at 1286.

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FDA Licensing Doctors Nurses 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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