Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. Not to spill the beans, but if you think that, you’d be wrong.

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FDA Compliance 52

SQA

MAY 17, 2022

ANVISA’s RDC 665/2022 (link in Portuguese) replaces previous regulations, including RDC 16/2013 and IN 08/2013, and went into effect on 02 May 2022. China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022. United States Food and Drug Administration (FDA) – Regulations and Guidances.

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FDA Compliance Informed Consent Hospitals 75

HIT Consultant

AUGUST 1, 2024

Clearly, the use of AI in medical imaging alone has grown exponentially, with nearly 700 FDA-approved AI algorithms across a variety of healthcare specialties as of the end of 2023 (up from just 50 in 2013). 171 of these were approved between October 2022 and October 2023 alone.

HIPAA 98

HIPAA Compliance FDA 98

Natalia Mazina

JUNE 26, 2023

The Drug Supply Chain Security Act (“DSCSA”) was enacted in 2013 with the goal of creating an interoperable electronic system to trace certain prescription drugs as they are distributed in the United States. The Act sets six compliance deadlines. 1] Visit FDA’s website for more information. [2]

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FDA Compliance 52

HIT Consultant

MAY 30, 2024

To protect this system against potential threats and the illegal movement of counterfeit drugs, the Drug Supply Chain Security Act (DSCSA) was enacted in 2013. Presently, we are in a “stabilization period” where the FDA is temporarily exercising enforcement discretion for specific requirements of the DSCSA.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Hospitals 52

Exeed Regulatory Compliance

JULY 31, 2020

In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease. If the answer is yes, then FDA may not issue an EUA. You can also watch a brief video about this process below.

COVID-19 52

COVID-19 FDA US Department of Health and Human Services Public Health 52

Hall Render

JANUARY 3, 2024

Liza Brooks is based in the firm’s Detroit office and focuses her practice on supply chain operations, health information technology and clinical research compliance. from the University of Michigan Law School in 2013. office and helps clients navigate the complex and ever-changing landscape of FDA regulation.

Fraud 40

Fraud Hospitals Compliance FDA 40

AIHC

JANUARY 28, 2022

For more information on filing compliance cost reports, attend the Medicare Cost Report Camp in March 2022 presented by KraftCPAs and sponsored by the American Institute of Healthcare Compliance. This is to allow eligible antimicrobial products to begin receiving the new technology add-on payment sooner. billion in FY 2021, or 2.7

Medicare 40

Medicare Medicare Hospitals Payment Systems 40

Verisys

NOVEMBER 14, 2023

Proven software and technology which continuously monitors these sources will ensure that your healthcare organization is in compliance at all times. With thousands of federal and state sources to screen for debarments, sanctions, exclusions, and disciplinary actions, manual monitoring of your provider population is virtually impossible.

Licensing 52

Licensing Medicaid Medicaid Governance 52

Verisys

JANUARY 18, 2022

Proven software and technology which continuously monitors these sources will ensure that your healthcare organization is in compliance at all times. Food and Drug Administration (FDA). ISO 27001:2013 (information security). System for Award Management (SAM). Specially Designated Nationals (SDN). Drug Enforcement Agency (DEA).

Licensing 52

Licensing Medicaid Medicaid Governance 52

SQA

AUGUST 2, 2021

ISO 13688:2013, Protective clothing – General requirements. ISO 13688:2013/AMD 1:2021, Protective clothing — General requirements — Amendment 1. ISO/TS 16976-8:2013, Respiratory protective devices – Human factors – Part 8: Ergonomic factors. United States Food and Drug Administration (FDA) – Guidances for Drugs and Biologics.

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

AUGUST 8, 2023

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. TR 43 applies solely to empty glass containers.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

JUNE 10, 2021

Implementation of regulatory requirements for the above device types had been set for 01 April 2021, but CDSCO cites the need for additional time to prepare for compliance in order to complete procedural work such as audits of facilities, query resolutions, and related issues. FDA plant inspection and pay $50 million in fines and forfeiture.

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COVID-19 FDA COVID-19 Vaccine Compliance 52

Healthcare IT Today

APRIL 24, 2023

Yet, from 2013-2017, 78% of the drugs approved by the FDA had only one dose regimen and of the drugs considered to be amenable to response-guided treatment, only 39% provided relevant dose instructions. These factors not only vary between individuals of different races, gender, age etc., but also in the same person over time.

Health Outcomes 86

Health Outcomes COVID-19 FDA Compliance 86

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 2d 277, 286 (Mich.

FDA 52

FDA Fraud Compliance Hospitals 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. 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 COVID-19 Vaccine 105

Drug & Device Law

SEPTEMBER 21, 2023

The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations. Ohio 2023).

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FDA Governance Compliance 59

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. 472 (2013), but that hinged largely on the duty of sameness—that is, the generic manufacturer cannot change the formulation of its drug to be different from the branded drug on which its ANDA approval depended.

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FDA Fraud Compliance 64

Drug & Device Law

JANUARY 30, 2023

472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

DECEMBER 6, 2022

According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. As it turns out, thanks to very specific language from both the FDA and Congress, neither could the presence of PHOs before 2018. Like with drugs, foods regulated by the FDA cannot be “adulterated.” Tootsie Roll Indus.

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FDA Compliance Governance 59

Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2013); Heisner v.

FDA 59

FDA Licensing Compliance 59

Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. This internal FDA decision was one of the reasons that preemption prevailed in Pfaff. T]he FDA responded. However, the FDA concluded that. . . [it

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FDA Compliance 59

Drug & Device Law

JUNE 28, 2022

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. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. 627, 636 (2013). 393(b)(1).

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FDA Public Health Federal Policy Doctors 116