SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

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Health Law Advisor

MARCH 1, 2023

On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). States and the federal government have been taking sides on the ability of pharmacies to dispense mail-order medications used for abortion. Utah Code § 58-83-306.

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Healthcare IT Today

DECEMBER 29, 2023

Sara Shanti, a partner specializing in health care technology at law firm Sheppard Mullin , says that the Executive Order and recent FDA guidance “start to provide real direction on how to navigate patient risk. Liability and Licensing Are clinicians facing the risk of lawsuits if they heed the advice of AI engines?

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SQA

MAY 24, 2023

ANVISA has intercepted international shipments of Batch Number C6835C3 which presented a false description of content and contained bottles in packaging in the Turkish language with expirations dates 10/2024 (bottle) and 12/2024 (secondary packaging). The written procedure for recall was inadequate and this procedure had not been implemented.

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Healthcare Law Today

DECEMBER 19, 2022

health care sector continues to grow at a rapid rate, and there is a recent government push for health care technologies, which have been identified as essential to U.S. market presents a tremendous opportunity for Israel-based health care companies, though the complexities and challenges of U.S. ” The U.S.

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Telemedicine FDA Licensing Governance 64

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. about how they use sunscreen products.

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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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Hall Render

MARCH 3, 2023

Clair Health partners with Duquesne University College of Osteopathic Medicine UPMC sees lower operating income in 2022 as economic headwinds persist UPMC settles lawsuit with federal government for $8.5

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Nursing Homes COVID-19 Nurses Hospitals 40

Hall Render

OCTOBER 6, 2023

government grant for maternal health care Alabama slides to 50th on nursing home and long-term care report card Ascension sells Alabama hospital Ascension St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

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US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

OCTOBER 6, 2023

government grant for maternal health care Alabama slides to 50th on nursing home and long-term care report card Ascension sells Alabama hospital Ascension St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

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US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

SQA

OCTOBER 18, 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. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. The ICH M12 Draft Guideline Presentation Available Now on the ICH Website, 15 July 2022.

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

Hall Render

FEBRUARY 2, 2024

Inman College of Nursing FDA clears Collierville startup CircumFix’s medical device for surgery, marketing FTC opposes Novant Health’s $320M hospital deal with Community Health Systems HCA CFO to retire HCA nets $5.2B for Dental Health OakLeaf Medical Network reaches out to HSHS WYOMING Gov.

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Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Hall Render

MARCH 25, 2022

FDA to revive facility visits. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. lawmaker presents plan to improve women’s healthcare. Federal government investigating over 2 dozen ‘major’ medical data breaches in the Carolinas. Here are the top health systems by patient reviews.

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

During the operation, food supplements, cannabidiol in various presentations, testosterone, perfumes, and sibutramine tablets were identified, including about 6,000 units of electronic cigarettes and 35,500 packs of cigarettes. The products found, subject to retention and seizure, were retained by the Federal Revenue Service.

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FDA Compliance COVID-19 Public Health 52

Kaiser Health News

APRIL 6, 2022

About 30% of its funding comes from government grants and contracts. In presentations, they often share a 2017 study — conducted by an independent research institute at TROSA’s request — which found TROSA saves the state nearly $7.5 Only 12 facilities are licensed to prescribe buprenorphine.

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Licensing Public Health FDA Doctors 83

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. at *2 (citation omitted).

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Drug & Device Law

NOVEMBER 1, 2022

Starting with the to-be-published Mixson I , this IVC filter case presented rather complex choice of law issues because the plaintiff implantee was in the military when the surgery in question occurred, and the army sent him to Texas for treatment, even though he was a Florida resident. 2022 WL 4364153, at *2. quoting Ariz. 12-689(A)(1)).

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FDA Fraud Licensing Governance 59

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

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

Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. Such power rests solely with the FDA.”

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Doctors Fraud Licensing Compliance 52

Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. After some FDA inquiries, the defendant eventually submitted a separate 510(k) application for the product, and it was cleared in May of 2008.

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Drug & Device Law

NOVEMBER 4, 2023

Bexis and Steve McConnell will be among your Reed Smith presenters. Our colleagues David Cohen and Mildred Segura will present “ You Be the Judge: Ethics Edition ,” a fun (we hope), interactive game that will test your knowledge of legal ethics rules surrounding e-discovery.

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FDA Pharmaceutical Industry Licensing Fraud 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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