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AI’s Ability to Manipulate Decision Making Requires a Moratorium on Its Use in Obtaining Consent for Biomedical Research

Bill of Health

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

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How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. The World Health Organization (WHO) has stopped short of classifying the outbreak as a pandemic, but consistently encouraged affected countries to activate their national emergency response plans.

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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The EC engaged Gesundheit Österreich GmbH (Austrian National Public Health Institute), Civic Consulting, and Areté to collect data on the availability of medical devices in the EU and the progression of transitions to the Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).

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

SQA

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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

SQA

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The EC engaged Gesundheit sterreich GmbH (Austrian National Public Health Institute), Civic Consulting, and Aret to collect data on the availability of medical devices in the EU and the progression of transitions to the Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.