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False and Deceptive Health Claims: Buyers Beware

Bill of Health

The FDA’s primary responsibility is over claims that appear on product labels (including packaging, product inserts, and promotional material at the point of sale), and the FTC regulates claims made in advertising in general. FDA regulations prescribe different standards for different products and claims. million to consumers.

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Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device was not Approved or Cleared before Commercialization

Healthcare Law Today

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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Navigating The Mental Health Challenges of an Aging Population

HIT Consultant

This trend is expected to accelerate, bringing with it various public health challenges, including a rising prevalence of late-life depression. Deep TMS has been successful in treating patients aged 22 to 68 since 2014. The treatment can be used alone or in conjunction with medication and/or talk therapy.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA

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’. United States Food and Drug Administration (FDA) – Regulations and Guidances.

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SQA Regulatory Surveillance Summary for May and June 2024

SQA

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. cosmetic regulatory framework. Consumer and product safety remains at the heart of our industry.

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FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

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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