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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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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 | 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.

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SQA Regulatory Surveillance Summary for March and April 2024

SQA

The adoption of these mechanisms is recommended and encouraged by the World Health Organization (WHO) so that the population has faster access to health services and technologies. In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

The EC presented a first draft for public comment to the revision of Annex 1 in 2017. The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA GMP/GDP Inspectors Working Group (GMDP IWG) in close co-operation with the European Commission (EC) and the World Health Organization (WHO).

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

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.

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